INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES

378-391

Authors: Narasimhulu. Kurra1*, Chandrasekhara Rao Baru1, Dr. Vidyadhara2, Dr. Vanitha Prakash.K

The present study was carried out to develop the Lisinopril sublingual tablets Lisinopril were available in 5 & 10 mg. In the present study 10 mg strength were prepared and evaluated for all the physical parameters evaluation and in-vitro drug dissolution studies. In the innovator preparation, Sodium Bicarbonate and Sodium Carbonate were used and the restriction was laid to the use of both the buffers. So, the generic version was prepared by using single buffer sodium carbonate. Sublingual Tablets of this drug is very essential to overcome the lack of compliance associated with higher dose of conventional oral swallowing tablets and also to protect the drug degradation from hepatic metabolism which can result in undesired pharmacological action. In vitro dissolution was carried out by using USP Apparatus Type-II at 75 rpm, using 6.8 pH phosphate buffer as dissolution medium recommended by office of generic drugs (OGD). The effect of diluents and superdisintegrants on the disintegration time and content uniformity was clearly studied in this research. Special emphasis was laid on the pH of the tablet as restriction was laid in using both the buffer systems. These sublingual tablets are used for treatment of insomnia. Sublingual tablets are developed because of their ease of administration and particularly insomniac patients will find great use of these sublingual tablets. KEY WORDS: Lisinopril,Sublingual,Insomnia

402-406

Authors: Azizur Rahman 1*, S Javed Ali 2, Mohammad Aslam3 Basharat Rashid4

Anticipation and endorsement of wellbeing is the solution for humanity to achieve the pleasing life. Some factors which are directly related to the health i.e Fresh Air (Hawae Muheet ), Food and Drink (Makool Mashroob), Body Movement and Repose (Harkat wa Sukoone Badania), Mental Movement and Repose (Harkat wa Sukoone Nafsania), Sleep and Wakefulness (Naum wa Yaqzah), Retention and Evacuation (Ehtibas wa Istafraagh). They are called as “Asbabe Sitta zarooriya” (Six Essentials of life) are the main factors to retain the health. Any alteration of above said six essentials interfere in the health and a disease occurs. Elegant Unani philosophers corroborated the knowledge regarding how one can save the health, using six essentials of life. Key Words: Asbabe Sitta zarooriya; Health; Unani Medicine; Six Essentials of life

420-429

Authors: Amit E. Birari1*, Jayshree S. Bhadane

The main objective of the present study is to design, evaluate and optimization of Metoprolol succinate orodispersible table (ODTs) with superdisintegrants. Orodispersible tablets disintegrate instantly on the patient tongue or buccal mucosa. It is suited for tablets undergoing high first pass metabolism and is used for improving bioavailability with reducing dosing frequency to minimize side effect. Various formulations of Metoprolol succinate tablets were prepared by direct compression method using different concentration of Superdisintegrants (Kollidon CL and croscarmellose sodium) 2.5% to 5 %. The blend of ingredients was evaluated for Angle of Repose (θ), Bulk Density, Carr’s Compressibility Index (CI) and Hausners Ratio. The Prepared tablets were evaluated for weight variation, thickness, hardness, friability, content uniformity, disintegration time and in vitro dissolution studies. All formulations were shows acceptable results for all the evaluation parameters and form the data formulation F4 was considered as an optimized formulation. Since it meets all standard requirements. Keywords: ODTs, Metoprolol succinate, Kollidon CL, croscarmellose sodium.

439-447

Authors: Mohd. Nadeem1, M. Suresh Babu1,

Quality by Design (QbD) is an approach in the design and development of the formulation by using different scientific strategies, tools and previous data available. QbD can assist the pharmaceutical industry and research scholars to satisfactorily move towards the more scientific, active, risk-based pharmaceutical development. Qbd, if applied, to the entire product cycle minimizes the end product testings and leaves one with safe, effective and quality product. In the present study, an attempt is made to apply the QbD to the Dextromethorphan, a highly potent opiod analgesic and antitussive drug which have relatively lesser addictive and narcotic properties. It is designed in immediate and extended release manner for better therapeutic efficacy. Due to the shorter half life of Dextromethorphan it needs to be taken four to five times a day. To reduce the frequency of dose it can be formulated in extended release form by wet granulation method. The tablets were prepared by direct compression of matrix-type immediate release layer and ethyl cellulose coated extended release layer in bilayered rotary press (Remik, Mini Press II DL). Physical mixture of drug and the excepients is found to be compatible when evaluated using FTIR and the tablets are evaluated for hardness, thickness, weight variation, friability, content uniformity, distintegration and dissolution profile. The effect of Binder, superdistintegrant and coating concentrations are also optimized by using the design space and other plots with the help of Minitabs Software version 17. The prepared formulation showed better dissolution profiles than the available products. Keywords: Dextromethorphan HBr, Quality by Design, Extended Release, Antitussive, Minitabs Version 17

456-465

Authors: G. N. V. Rama Raju1*, A. Sambasiva Rao2, Nansri Saha1, K. Mamatha1, Chandrasekhara Rao. Baru

Montelukast sodium is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor. Montelukast causes inhibition of airway cysteinyl leukotriene receptors as demonstrated by the ability to inhibit bronchoconstriction due to inhaled LTD 4 in Asthmatics. Doses as low as 5 mg cause substantial blockage of LTD 4 -induced bronchoconstriction. Montelukast biological half life is 2.5 to 5.5 hrs, thereby decreasing bioavailability up to 64%. So in order to improve the bioavailability and efficacy we have designed matrix release tablets. The prepared matrix tablets found to have good precompression and post compression parameters. The swelling performance, release rate features and the in vitro dissolution study. The drug release kinetics from optimized F-5 formulation showed zero order release. The study concludes to retard the release of Montelukast from the tablets. Keywords: Montelukast sodium, HPMC, matrix tablets, sustained release

284-294

Authors: U.Karuna*1, Ch.Ramakrishna 2, R.Shireesh Kiran 3 , Dr .V. Umamaheshwar Rao

Oral sustained release gastroretentive dosage forms offer many advantages for drugs with absorption from upper parts of gastrointestinal tract and for those acting locally in the stomach. Floating drug delivery system is one amongst the gastroretentive dosage forms used to achieve prolonged gastric residence time. Bilayer floating drug delivery system is combined principle of bilayer tablet as well as floating mechanism. Bilayer floating tablet is new era for the successful development of controlled release formulation along with various features to provide a way of successful drug delivery system. Bilayer floating tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one layer is immediate release as initial dose and second layer is maintenance dose. The purpose of this paper is to review the current technology used in the development of bilayer floating drug delivery system as well as summarizes the applications, characterization, evaluation methods and future potential for bilayer floating tablets. KEYWORDS: Bilayer Floating Tablets, GRDDS

305-314

Authors: Md. Khaja *, Muneer Syed, D. Srinivasa Rao

Captopril was the first ACE inhibitor used for the treatment of hypertension. The present study was aimed to design and evaluate a matrix-type transdermal formulation containing captopril with different ratios of hydrophilic (Hydroxy propyl methyl cellulose E-15) and hydrophobic polymeric (Eudragit RS100) combinations plasticized with glycerin by the solvent evaporation technique. Effect of permeation enhancers such as oleic acid, dimethyl sulfoxide (DMSO) and dimethyl formamide (DMF) were studied. The interference of the polymers was ruled out by FT-IR studies. The prepared patches were tested for their physicochemical characteristics such as physical appearance, weight variation, thickness, folding endurance, percentage moisture absorption, percentage moisture loss, water vapour transmission, tensile strength and drug content. In vitro release studies of captopril loaded patches in phosphate buffer (pH, 7.4) exhibited drug release for 24 hours in the following order F3< F6< F5< F4. Data of in vitro release from patches were fit in to different equations and kinetic models to explain release kinetics. The models used were zero and first-order equations, Higuchi and Korsmeyer-Peppas models. Based on physicochemical properties and in vitro release studies, patch containing hydroxyl propyl methyl cellulose E-15 and Eudragit RS 100(1:1) with oleic acid as permeation enhancer, emerges as a best formulation. Skin irritation studies for the transdermal patches were assessed and were found to be free of irritation. Key words: Captopril, hypertension, transdermal formulation, kinetic models.

323-327

Authors: Y. Kranthi Kumar1*, Y. Malyadri2, K. Shishir Chandra Sharma3

The present study deals with nephrotoxicity in humans and we can use ocimum sanctum plants aqueous leaf extract as nephron protective in kidneys. The purpose of pharmaceuticals research is to develop new drugs. The present research work done on gentamicin induced nephrotoxicity rats by doing experimentation. Aminoglycoside antibiotics including gentamicin are widely used in the treatment of gram-negative infections. However the major complication of the use of these drugs is nephrotoxicity, accounting for 10-15% of all cases of acute renal failure. The nephrotoxicity of gentamicin is well established in man & experimental animals. Gentamicin induced nephrotoxicity was ameliorated by various mechanisms among which oxidant mechanism was chosen by us to proceed in experimentation. The experimentation follows by various steps in nephrotoxicity rats and by the plant’s leaves extract of ocimum sanctum is induced in rats and the resulting the disease can be controlled and various factors are shown by comparing creatinine levels and factors required to decrease the nephrotoxicity occurred by using antibiotics. Keywords: Ocimumsanctum, Gentamicin, Nephrotoxicity

333-336

Authors: Ravindra. N

Two simple and sensitive visible spectrophotometric methods have been developed for the quantitative estimation of Tramadol Hydrochloride from its tablet formulation. The developed methods are based on formation of chloroform extractable colored complex of drug with metanil yellow and tropaeolin ooo. The chloroform extracted complex of drug with metanil yellow showed absorbance maxima at 410.0 nm and linearity was observed in the concentration range of 3-24 μg/ml (method-I), with tropaeolin ooo showed absorbance maxima at 485.0 nm and linearity was observed in the concentration range of 3-24 μg/ml (method-II). Results of analysis for both the developed methods were validated statistically and by recovery studies. Key words: Tramadol Hydrochloride, Chloroform extract, Absorbance, Metanil yellow and Tropaeolin ooo.

343-346

Authors: A. John De Britto*, P. Benjamin Jeya Rathna Kumar and D.Herin Sheeba Gracelin

In the present study the antibacterial activity of methanol extracts of different parts of N. nimmoniana was tested against two bacteria. The similar work was carried out by John De Britto and Herin (2011a) in Datura metel. For that plant the leaves and flowers showed significant inhibitory effects. But in the present work, the seeds of the selected plant exhibited potential inhibition against the selected bacteria. John De Britto and Herin (2011b) reported the biocontrol of Xanthomonas campestris using the methanol extracts of different parts of Azadiracta indica. Hence to achieve the successful results in bio control of pathogens and screen the potential medicinal properties of N. nimmoniana, the present work was carried out. The investigation provides successful positive results.

353-358

Authors: K.Joney*, Muneer Sayed, D. Srinivas Rao

To investigate the antidepressant activityof the spray dried powder of Spirulinaplantensis which was used for the treatment of depression in different doses and Imipramine is used as standard drug in experimental animals. The evaluation is done by conductingthe followingtests like5-HT induced head twitches, forced swim test, Tail suspension test, Clonidine induced aggression behaviour, L-dopa induced hyper activity and aggressive behavior. The animal models used for conducting the tests are albino mice (20-30 g) of either sex. From the results of all the experimental models it was observed that Spirulina is showing the antidepressant activity which was dose dependent. Key words: Spirulina, Depression, Imipramine, 5-HT, Clonidine, L-dopa.

373-377

Authors: M. Harish Reddy1,* K. Sambasivarao2

The cardiovascular diseases (CVDs have been the major cause of morbidity and mortality in developed countries over the last several decades, and developing countries are rapidly catching up with this epidemic. The underlying pathology is athermanous vascular disease, resulting in coronary artery disease (CAD), cerebrovascular disease, and peripheral vascular disease, and the subsequent development of heart failure and cardiac arrhythmias. The major risk factors for these disorders were recognized over many years, and they include high levels of low-density lipoprotein (LDL) cholesterol, smoking, hypertension, diabetes, abdominal obesity, psychosocial factors, insufficient consumption of fruits and vegetables, excess consumption of alcohol, and lack of regular physical activity. There has been continued research to help define more precisely the cardiovascular risk of an individual with respect to genetic factors, more complex lipid traits, and inflammatory markers, but it was reconfirmed in the INTERHEART study that the conventional risk factors accounted for over 90% of the population attributable risk for myocardial infarction There is extensive evidence to show that drug treatment of conventional risk factors is effective in reducing cardiovascular events. Many large clinical trials with the HMG CoA reductase inhibitors (statins) have showed that lowering of LDL cholesterol with these agents decreases coronary and cerebrovascular events and that the target for LDL cholesterol becomes lower with each new set of guidelines and the availability of more potent drugs Likewise, more effective treatment of hypertension with various classes of antihypertensive drugs has been associated with greater benefits but some recent studies suggest we may be reaching the optimal level of treated blood pressure in some patient groups. Apart from the treatment of cardiovascular risk factors with pharmacological agents and the use of antithrombotic drugs, there is growing awareness of the role of dietary factors and herbal medicines in the prevention of CVD and the possibility of their use in treatment. A wide variety of plant extracts have been used in traditional medicine over the centuries and some, such as digoxin, have been adopted in conventional medicine. In this section, we concentrate on those plants and herbs for which there is some evidence, if not final proof, supporting their value in the prevention or treatment of CVD. More detailed reviews can be found elsewhere in the literature. Key Words: Cardiovascular, Cholesterol.

196-208

Authors: G. Ram Babu*, M. Prasad Rao, M. Rama Kotaiah , K. Ratna Rajeev

Pioglitazone Controlled release tablets were prepared by using polymers like Hydroxy propyl methyl cellulose, Psyllium, Guar-gum, Xanthum gum and Carbopol. From this study it can be concluded that Pioglitazone C.R tablets prepared by Hydroxy propyl methyl cellulose K15M ( i.e. H3) showed good release rate than the tablets prepared by using other polymers. Pre compression and Carr’s index of the pure drug indicated that the drug had good flow property, even the formulations were found to be within the range. Post compression studies, for tablets like thickness, diameter, hardness, friability, drug content uniformity was done. The dissolution studies were carried out for 24 hours. As per the result of dissolution study of formulation H3, P3, G3 and X3 showed reasonable release 99.87%, 97.85%, 92.48% and 93.51% respectively at the end of 24hrs. Formula H3 showed good drug release profile 99.87% at the 24 hrs, showed excellent matrix integrity during the period of study, when compare to other formulations. The formulation H3 was considered optimum because it showed negligible drug release in acidic medium and drug release in the phosphate buffer (pH 7.4) was found to be almost complete. The stability studies of the selected formulation showed that the product was stable through-out the study period .

219-229

Authors: Spurthy Kassey *, Ravi Pratap Pulla, K. Vanitha Prakash

ABSTRACT A simple, sensitive ,linear, precise and accurate PR-HPLC method for simultaneous estimation of isosorbide dinitrate and hydralazine hydrochloride, in tablet formulation was developed, validated and forced degradation studies were conducted. The chromatographic separation of the two drugs was achieved on INERTSIL ODS C18(150 x 4.6 *5μ) column in an isocratic mode. The mobile phase consisting of 0.1M sodium dihydrogen phosphate:methanol in the ratio of 80:20 v/v and was delivered at a flowrate of 1ml/min and effluents were monitored at 270nm. The retention time of was found to be 1.679 and 3.430 min, respectively. Calibration curves were linear with acorrelation coefficient of 0.994 for HYD, and 0.997 for ISDN over the concentration range of 160-480 g/ml for ISDN, and 300-900 g/ml for Hydralazine HCl and precise with (%RSD <2). The method was validated as per the ICH guidelines and drugs were found to be stable under forced degradation conditions and can be employed for routine Q.C.analysis. Key words: Isosorbide dinitrate, Hydralazine HCl, RP – HPLC, Simultaneous estimation, Method validation and ICH guidelines

241-251

Authors: Nirlep Kaur

Gastroretention helps to provide better availability of new products with new therapeutic possibilities and substantial benefits for patients. Dosage forms with a prolonged gastric residence time, i.e. gastro retentive dosage forms (GRDFs), will provide us with new and important therapeutic options. GRDFs extend significantly the period of time over which the drug may be released. Thus, they not only prolong dosing intervals, but also increase patient compliance beyond the level of existing controlled release dosage forms. This application is especially effective in delivery of sparingly soluble and insoluble drugs. A number of approaches have been used to increase the GRT of a dosage form in a variety of concepts. These include Floating drug delivery systems, Bioadhesive systems, Swelling and expanding systems, Modified shape systems and High density drug delivery systems. This review also discusses the recent advances in the field of gastroretentive drug delivery systems. KEYWORDS: Delivery System, Gastroretentive, Gastric Residence Time, Bioavailability.

260-265

Authors: Gogulamudi Anusha*, R. Kalaichelvi

The present proposed RP- HPLC method was found to be simple, rapid, precise, accurate and sensitive for the determination of Tolvaptan (TPT) in bulk and pharmaceutical dosage form. The separation was achieved on RP-HPLC with using a PDA detector by incorporation of empower2 software with the flow rate 1 mL/min using Buffer: Acetonitrile (45:55 %V/V) as mobile phase in the column Nucleosil-C18 (250 x 4.6 mm, with 5μm) at a wavelength of 264 nm with a run time of 10 mins. The retention time was found to be 4.536 min and data was linear at 25- 150 μg/mL for TVT successively. The Limit of Detection (LOD) and Limit of Quantification (LOQ) was 0.025 and 0.075 respectively for TVT. The percentage recoveries for tolvaptan was found to be 101.28% and the method developed and validated in terms of accuracy, precision, linearity, range, robustness, LOD, LOQ are according to ICH guidelines. So, the method can be useful for the day to day routine analysis in the quality control departments of bulk and pharmaceutical formulations industries. Keywords: Tolvaptan, PDA (PhotoDiode Array), ICH and RP-HPLC.

275-283

Authors: K. Rama Krishna*

Fast dissolving films have been playing one of the important role in the current pharmaceutical research because of their convenience and ease of use over other dosage forms such as orally disintegrating tablets and immediate release tablets. In the current research, rapidly dissolving films of Loratidine were developed using low viscosity grades of HPMC and pullulan gum as film forming polymers. HPMC is a synthetic polymer which is water soluble. It is used as film former from many years. Solvent casting method is employed for the preparation of the films of Loratidine using di-chloromethane and methanol as solvents. The prepared films were evaluated for drug content, weight variation, thickness and in vitro in vivo disintegration time. Loratidine is moderately bitter drug. The taste masking was achieved by use of sweeteners and flavours. The in vitro disintegration time of the prepared formulation was found to be in the range of 18 to 50 seconds respectively. The prepared films exhibit good integrity and thickness. In vitro dissolution studies were performed as per the FDA dissolution guidelines for about 30 minutes. The optimum formulation release complete drug within 15 minutes. DSC and FTIR studies showed no drug polymer interaction. Key words: Fast dissolving films, HPMC, Loratidine, Solvent casting method,

136-141

Authors: Pallavi.K

Cancer is major health problem in both developed and developing countries. Cancer after cardiovascular disease is the second leading cause of death. Cancer is the abnormal growth of cells in our bodies that can lead to death. Because of high death rate associated with cancer and because of serious side effects of chemotherapy and radiation therapy, many cancer patients seek alternative complementary methods of treatment. Medicinal herbs play an important role in primary health care system among rural population since synthetic anti-cancer remedies are beyond the reach of common man because of the cost factor. The herbal medicines have a vital role in the prevention and treatment of cancer which execute their therapeutic effect by inhibiting cancer activating enzymes and hormones, stimulating DNA repair mechanism, promoting production of protective enzymes inducing anti-oxidant action and enhancing immunity

142-150

Authors: Ayesha Begum K*, Sandhya Pamu, Geetha Kodali, Pavani Kasu

Repaglinide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). A new RP-HPLC method was developed for the estimation of Repaglinide which is simple and less time consuming using an economical column. The analysis was resolved by using a mobile phase (Potassium di hydrogen phosphate: Methanol (80:20)) at a flow rate of 1 ml per minute using ACE- C18 (250 x 4.0, 5 microns) on an isocratic HPLC system. There was no interference observed from other impurities and Repaglinide has been eluted with good peak shape, response within 12 minutes and retention time at 3.016 minutes. The detection was made at 285 nm.The assay of the sample has been carried out using this new method and it was found to be 99.7%. The developed method has been validated for different parameters like Specificity, Precision, Linearity, Accuracy, Robustness, Limit of Detection (LOD) and Limit of Quantitation(LOQ) are studied as reported in the International Conference on Harmonization (ICH) guidelines. All the results obtained were within the acceptance limits indicating that the developed method is simple, specific accurate and economical. The method may now be recommended for routine and quality control analysis of Repaglinide. Key Words: Repaglinide,

171-181

Authors: Abdeen M. Omer and Gamal K. M. Ali

The strategy of price liberalisation and privatisation had been implemented in Sudan over the last decade, and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatisation policy, the government introduced radical changes in the pharmacy regulations. The 2001 Pharmacy and Poisons Act and its provisions established the Federal Pharmacy and Poison Board (FPPB). All the authorities of the implementation of Pharmacy and Poisons Act were given to this board. This article provides an overview of the impact of the pharmaceutical regulations on the quality of medicines on the Sudanese market from the perspective of the pharmacists working with drug importing companies. The information necessary to conduct the evaluation was collected from 30 pharmacists who are the owners or shareholders in medicines’ importing companies. The participants were selected randomly. 89% of respondents considered the medicines on the Sudanese market are generally of good quality. The design of the research itself may be considered inadequate with regard to selection process. However, the authors believe it provides enough evidence, and the current pharmaceutical regulations have some loopholes. The Pharmacy, Poisons, Cosmetics and Medical Devices Act-2001 and its regulation should be enforced. The overall set-up including the Act itself needs to be revised

59-69

Authors: Abdeen M. Omer , and Gamal K. Ali

Abstract: Worldwide there are different systems for providing pharmacy services. Most countries have some element of state assistance, either for all patients or selected groups such as children, and some private provisions. Medicines are financed either through cost sharing or full private. The role of the private services is therefore much more significant. Nationally, there is a mismatch between the numbers of pharmacists and where are they worked, and the demand for pharmacy services. The position is exacerbated locally where in some areas of poor; there is a real need for pharmacy services, which is not being met and where pharmacists have little spare capacity. Various changes within the health-care system require serious attention be given to the pharmacy human resources need. In order to stem the brain drain of pharmacists, it is, however, necessary to have accurate information regarding the reasons that make the pharmacists emigrate to the private sector. Such knowledge is an essential in making of informed decisions regarding the retention of qualified, skilled pharmacists in the public sector for long time. There are currently 3000 pharmacists registered with the Sudan Medical Council of whom only 10% are working with the government. The pharmacist: population ratio indicates there is one pharmacist for every 11,433 inhabitants in Sudan, compared to the World Health Organisation (WHO) average for industrialised countries of one pharmacist for 2,300 inhabitants. The situation is particularly problematic in the Southern states where there is no pharmacist at all. The distribution of pharmacists indicates the majority are concentrated in Khartoum state. When population figures are taken into consideration all states except Khartoum and Gezira states are under served compared to the WHO average. This mal-distribution requires serious action as majority of the population is served in the public sector. This study reveals the low incentives, poor working conditions, job dissatisfaction and lack of professional development programmes as main reasons for the immigration to the private sector. The objective of this article is to highlight and provide an overview of the reasons that lead to the immigration of the public sector pharmacists to the private sector in Sudan. The survey has been carried out in September 2004. Data gathered by the questionnaires were analysed using Statistical Package for Social Sciences (SPSS) version 12.0 for windows. The result have been evaluated and tabulated in this article. The data presented in this paper can be considered as nucleus information for executing research and development for pharmacists and pharmacy. More measures must be introduced to attract pharmacists into the public sector. The emerging crisis in pharmacy human resources requires significant additional effort to gather knowledge and dependable data that can inform reasonable, effective, and coordinated responses from government, industry, and professional associations. Keywords: Sudan, Health care, Pharmacy, pharmacist retention, private sector, public sector.

90-97

Authors: RLC Sasidhar*, S.Vidyadhara, T.Balakrishna, K.Vijetha and V. Kasaiah

Abstract Paroxetine Hydrochloride is a potent and selective inhibitor of 5-hydroxytryptamine (5-HT, serotonin) uptake. It is a BCS class – I drug used in the treatment of depression and anxiety disorders. Paroxetine HCl undergoes extensive first-pass metabolism leading to poor bioavailability. The aim of present work is to formulate and evaluate Paroxetine HCl fast dissolving tablets prepared by direct compression method using super disintegrants like sodium starch glycolate, directly compressed lactose, and microcrystalline cellulose as diluents and menthol as sublimating agent. The prepared tablets were evaluated for uniformity of weight, thickness, friability, content uniformity, hardness, disintegration time, wetting time and for in vitro drug release. Further the tablets were characterized by fourier transform infra red spectroscopy. Among all the formulations the tablets prepared by menthol with sodium starch glycolate as super disintegrant containing lactose as diluents showed faster disintegration and rapid drug release. Key words: Paroxetine Hydrochloride, sodium starch glycolate, directly compressed lactose, Sublimation.

107-115

Authors: Kalpana Nekkala*, Dr. V.Shanmukha Kumar J1, Dr.D.Ramachandran, Dr. Ganji Ramanaiah, Ganta Srinivas

ABSTRACT A rapid and sensitive Reverse Phase High Performance Liquid Chromatographic [RP-HPLC] method was developed for the estimation of Loratadine [LRD] in pure and its capsule dosage forms. The method was validated as per International Conference on Harmonization [ICH] guidelines. The mobile phase containing a mixture of dibasic potassium phosphate buffer (pH-7.2), methanol and Acetonitrile in the ratio of 7:6:6% v/v. Zodiac C-8 column (150×4.6mm, 5μm) was used. The analysis was performed with run time of 30 minutes at a flow rate of 1.0ml/min. The LRD was monitored at 254nm with UV detection and LRD was eluted at 22.0 min. The method was linear (r2 =0.999) at concentration ranging from 25.0 to 150μg/ml, precise (intra-day relative standard deviation [RSD] and inter-day RSD values < 1.0%), accurate (mean recovery = 99.5%), specific and robust. Detection and quantification limits were 20.0μg/ml and 61.0μg/ml, estimated from linearity by regression respectively. The results showed that the proposed method is suitable for the precise, accurate and rapid determination of LRD in bulk, its capsule dosage forms. Keywords: Loratadine, RP-HPLC, Validation, Dosage form.

125-135

Authors: Mogili Swetha* , Ravi Pratap Pulla & K.Vanitha Prakash

ABSTRACT A RP-HPLC method was developed and validated for the simultaneous estimation of Acetyl cysteine and Taurine in tablets. The proposed RP HPLC method utilized a AgilentC18, 4.6×150 mm, 5 µ column, mobile phase comprised of 0.01N KH2PO4 and Methanol in the ratio 60:40 v/v and flow rate 1 ml/min. The retention time for Acetyl cysteine and Taurine were found to be 1.722 min and 2.696 min. The linearity was in the range of 300 – 900 µg/mL (r = 0.999). The percentage recovery was found to be specific, linear, accurate, precise, rugged and robust. Force degradation studies were carried out for acidic, alkaline, oxidative, reductive and photolytic exposure of the drug substance and drug product. Hence the RP HPLC method developed and validated can be used routinely for the simultaneous estimation of Acetyl cysteine and Taurine in tablets Key words: Acetyl cysteine and Taurine, RP – HPLC, Simultaneous estimation, Method validation and ICH guidelines