International Journal of Pharmaceutical Sciences and Drug Research

287-290

Authors: Mehul K. Bhatt1*, Nehal Shah2

The anti-urolithiatic action of Hygrophila salicifolia (Acanthaceae) was determined by ethylene glycol induced lithiasis. Ethylene glycolated water (0.75% v/v) was given to experimental animals for 28 days to produce stone in kidney. Methanolic extracts of Hygrophila salicifolia were given from the 1st day as inhibitory agent. Urinary parameters such as calcium, oxalate and inorganic phosphate level were raised by ethylene glycol where as test extract lowered down the raised level of these ions in urine. Methanolic extract of Hygrophila salicifolia also increased urinary magnesium concentration while raised concentration of serum creatinine was found to be cut down during the experiment. Methanolic extract of test drug was found impressively better from histological study. These results obtained from the study confirmed the anti-urolithiatic potential of Hygrophila salicifolia.

295-298

Authors: Lekhni Soni, Rupesh K Gautam*

The present investigation is aimed to evaluate anti-arthritic activity of the ethanol extract of root of Momordica charantia (EEMR) by using Freund’s complete adjuvant (FCA) induced arthritis model which is a extensively used model for in-vivo study of anti-arthritic activity. Arthritis assessment was carried out on basis of parameters i.e. arthritis score, joint diameter and paw volume. The standard drug was diclofenac sodium. The findings of present study showed that EEMR in dose of 400 mg/kg produced more significant reduction in arthritis score, joint diameter and paw volume as compare to 200 mg/kg. On the basis of results, it can be concluded that EEMR showed significant anti-arthritic activity. It may be due to presence of phytocompounds such as flavonoids, alkaloids, tannins etc.

249-253

Authors: Himanshu A Acharya*, Rakesh P Patel

Hydralazine hydrochloride has a half-life of 2 to 4 hours with an oral bioavailability of 26-50%. Since hydralazine has a demethylating effect on various suppressor genes, it can be used in various types of cancer to support chemotherapy. The purpose of this study was to optimize and evaluate floating tablets of hydralazine hydrochloride designed to prolong the gastric residence time and to provide controlled release of the drug for 24 h. The floating tablets of hydralazine hydrochloride were prepared by the wet granulation method. Polymers of hydroxy propyl methyl cellulose (HPMC K100M), HPMC K15M, carbopol 940 and sodium bicarbonate were used as the release retarding agents. This study investigated utility of a 3-factor, 3-level Box-Behnken design and optimization process for floating tablet of Hydralazine with 5 replicates of center points. Amount of HPMC K4 (Hydroxy Propyl Methyl cellulose), amount of sodium bicarbonate were selected as the independent variables whereas total floating time (TFT), T90, % cumulative drug release at 24 hours, and T20, Q1 were selected as dependent variables. Non-Fickian diffusion release transport was confirmed as the release mechanism for the optimized formulation and the predicted values agreed well with the experimental values. Drug excipient compatibility studies were investigated by FTIR, DSC and XRD. The produced tablets exhibited good floating time and controlled drug release over a period of 24 h. The resultant data were critically analyzed to locate the composition of optimum formulations. All predicted values of response variables of optimized formulation demonstrated close agreement with the experimental data during optimization procedure.

259-264

Authors: Susheel Thakur*, Nisha Thakur, Niladry Shekar Ghosh

Arthritis is the condition which is associated with inflammation of a joint, pain, swelling, and stiffness. Drug delivery to the target site remains a challenge due to ineffective drug delivery system. An attempt has been made to formulate and evaluate micro-emulgel for the effective drug delivery in the treatment of Arthritis. Micro-emulgel was loaded with Curcumin and Tinospora cordifolia to enhance bioavailability of extracts which have been widely used in the treatment of arthritis. Micro-emulgel was prepared by emulsion-solvent diffusion method using carbopol 940P as a gelling agent. Micro-emulsion was formulated using Liquid paraffin oil as oil phase; Tween 80 and Span 20 as surfactant and co-surfactant respectively. FTIR studies proved the compatibility between drug, excipient and carbopol. The Prepared micro-emulgel was subjected to various parameters such as pH, rheological studies, spreadability, thermodynamic stability tests, drug content, electro conductivity, and in-vitro release studies. The pH of all formulations was found near to the skin pH value. Viscosity and spreadability of F1 optimized formulation was found to be 146.5×103 cPs and 2.24 g×cm. From the in vitro drug release study, it was revealed that sustained release of formulation last up to 18 hours. F1 formulation showed the highest drug release of Curcumin (92.37%) and Tinospora cordifolia (90.75%). SEM images showed the diameter of oil globules of Micro-emulgel were in range of 1.50 to 2.13µm. Drug release kinetics showed the zero order drug release from the optimized F1 formulation. From the stability studies, F1 formulations had an excellent physical stability.

269-274

Authors: G. Rajeswari Gopal1*, G.I. Anuja2, P.G. Latha2, A. Jayakumaran Nair1, A. Gangaprasad4, P.R. Sudhakaran1, D. Muraleedharan3, G.M. Nair1

In the present study the roots and leaf ethanolic extracts of Chassalia curviflora were screened for their anti hepatotoxic and anti oxidant effects in experimentally induced liver injury by carbon tetra chloride. Liver serum marker enzymes as well as antioxidant enzymes mainly superoxide dismutase, catalase and glutathione levels were determined. The plant root and leaf ethanolic extracts at 50, 100, 200 mg concentrations significantly (**P ≤ 0.05) reduced the elevated serum hepato specific enzyme [serum glutamate pyruvate transaminase (SGPT), serum glutamate oxaloacetate transaminase (SGOT), serum alkaline phosphatase (SAKP), serum bilirubin (SB)] and cholesterol levels induced by CCl4. Antioxidant enzymes such as superoxide dismutase (SOD), catalase (CAT) and non enzymatic reduced glutathione (GSH) levels were increased whereas malondialdehyde (MDA) level was reduced by the extracts. Compared to the leaf extract, root extract significantly reduced serum hepato parameters and increased the levels of anti-oxidant enzymes in a dose dependent manner. The results were comparable to that of silymarin, reference drug used for the study. The histopathological studies also supported the biochemical findings. Acute toxicity studies revealed that it is safe for pharmacological uses upto 2000mg/kg. The present study scientifically validated the traditional use of plant root in hepatoprotection.

199-203

Authors: J. S. Shah1*, J. B. Patel2, S. Dani3

Coronary Artery Disease (CAD) occurs when the arteries of the heart that normally provide blood and oxygen to the heart are narrowed or even completely blocked due to clot formation. The Stenting implantation composes 84.2% of all Percutaneous coronary intervention (PCI). Despite the widespread use of these devices, bare metal stents (BMS) have been associated with a 20-30% restenosis rate which requires reintervention. In December 2006, US Food and Drug Administration cardiovascular experts concluded that for many patients, such as those with uncomplicated medical histories who undergo elective stenting of simple coronary blockages, drug-eluting stents remain a safe and appropriate therapy. Previously reports are suggestive of similar clinical outcomes for stainless steel and cobalt chromium bare metal stent. No reports are available for comparison of sirolimus eluting stainless steel stent and sirolimus eluting cobalt chromium stent. The present study was undertaken with the objective of comparative evaluation of Stainless Steel Stent (Sirolimus) and Cobalt Chromium Stent (Sirolimus) in Patient with Coronary Artery Disease. A single centric, retrospective, non-randomized study involving 118 patients who have undergone PCI from January 2011 to March 2012 implanted with either Sirolimus Stainless Steel Stent (SSSS) or Sirolimus Cobalt Chromium Stents (SCCS) were included in the study. Primary objective was to determine and compare the clinical outcome and rates of target vessel revascularization (TVR) in patients undergoing primary PCI for CAD patients who were treated with Sirolimus cobalt-chromium stents and Sirolimus stainless steel stents. The secondary outcomes of study were Major Adverse Cardiac Events, mortality at the end of 1 month, 6 month and 1 year of outcomes. At 1 month follow up there was no significant difference between two groups (p = 0.96). The individual clinical component showed no difference in occurrence of death (p = 0.29), MI (p = 0.29) and TLR (p = 0.96) at end of 6 month. The cumulative clinical outcome at 1 year rate of target vessel revascularization TVR (SSSS 1.75% versus SCCS 0%, p = 0.29), target lesion revascularization (SSSS 5.27% versus SCCS 1.63%, p = 0.27), and Major Adverse Cardiac Events (SSSS 22.80% versus SCCS 13.11%, p = 0.16). This study showed that among Coronary artery disease (CAD) patients undergoing primary percutaneous coronary intervention, sirolimus stainless steel stent showed similar efficacy and safety to sirolimus cobalt chromium stent.

210-217

Authors: CM Detroja1*, LD Patel2, PR Vasanani3

Factorial design enables researchers to study and understand how multiple factors affect a dependent variable, both independently and jointly. In present report, 33 factorial design was used to study the combined influence of three independent variables in preparation of Simvastatin loaded Poly (D, L Lactide -co- Glycolide) (PLGA) nanoparticles. Nanoparticles were prepared by nanoprecipitation method. The process variables like rate of addition of organic phase to aqueous phase, temperature, speed of magnetic stirrer and time to evaporate organic phase were kept constant throughout the investigation. The formulation variables like concentration of stabilizer (Polyvinyl alcohol), drug (Simvastatin): polymer ratio (PLGA), and organic (acetone): aqueous phase ratio were selected as independent variables. Prepared nanoparticles were evaluated for particle size (PS) and entrapment efficiency (EE). PS and EE were selected as dependent variables. The coded values of independent variables were subjected to multiple regressions to derive a second order polynomial equation (full model). After neglecting the non-significant terms from full model, F-Statistics was applied to set up reduce polynomial equation. Among the three independent variables, value of coefficient of drug: polymer ratio was found to be maximum. This revealed that major contributing variable for PS and EE in nanoparticles is drug: polymer ratio. Two dimensional contour plots and three dimensional response surface plots were established by varying levels of two factors and keeping the third factor at fixed level at a time. Thus the derived equation, surface response plot and contour plot helps in predicting the value of independent variables for optimum PS and EE in preparation of Simvastatin loaded PLGA nanoparticles.

223-228

Authors: Paras R. Vasanani1*, L. D. Patel2, Chetan M. Detroja3

Nanosuspensions are the dispersions of nanosized particles in a suitable vehicle prepared using surfactants or solubilizers to aid in nanosize distribution. Nanosuspension is best suited for dosage form development of poorly soluble drugs. According to the biopharmaceutical classification system, drugs with poor solubility fall either in BCS class II or BCS class IV. BCS class II drugs show poor solubility and good permeability; hence their bioavailability problems can be overcome by improving their solubility. Metaxalone is one such BCS class II drug from an oxazolidin-2-one class of centrally acting muscle relaxant drugs, indicated for relief of discomforts associated with acute, painful musculoskeletal conditions. Therefore, in present investigation, nanosuspension of Metaxalone has been formulated as an attempt to improve solubility and hence the overall bioavailability of Metaxalone. Media milling technique has been employed for nanosuspension preparation. Surfactant concentration (Poloxamer 407) and stirring time has been optimized using 32 factorial design to achieve desired particle size and saturation solubility responses as dependent variables. The particle size (PS) of 215.3 nm and maximum saturation solubility (SS) of 2805μg/ml was obtained as suggested solutions from factorial design which was further confirmed using check point analysis. Interaction of surfactant concentration and stirring time and their effect on particle size and saturation solubility was predicted using the contour plots and response surface plots. The optimized formulation showed around 99% metaxalone in vitro dissolution in comparison to around 46% dissolution from SKELAXIN® tablet at 30 minutes. These methodologies could therefore be employed successfully to improve solubility of any BCS class II drug and to predict effects and interactions of many experimental variables at the same time.

235-239

Authors: G. Prakash Williams1*, Anju Anand1, Parvathy A1, Rakky C. Raj1, Robert Raju1, S. Krishna Kumar2

Living organisms can be found over a wide range of extreme conditions. Most of the organisms living in extreme environments (i.e, extremophiles) belong to the prokaryotes. Halophiles are interesting class of extremophilic organisms that have adapted to harsh, hypersaline conditions. They are able to compete successfully for water and resist the denaturing effects of salts. The present study was an investigation on the in vitro antibacterial effect of secondary metabolites from halophilic bacteria isolated from salted fish samples. The cured salted fish samples were collected and enumerated using halophilic Nutrient Agar supplemented with 4% NaCl. The isolated and purified bacterial cultures are numbered as SF1, SF2, SF3, SF4 and SF5 are further identified using VITEK 2 system as Bacillus vallismortis, Ralstonia mannitolytica, Bacillus subtilis, Rhizoboum radiobacter and Kocuria kristina. Growth kinetics of halobacterial isolates were determined by spectrophotometric assay. The antibiotic resistance pattern of tested pathogenic microorganisms using the commercial antibiotics was screened and almost all the tested microorganisms are resistant to Penicillin. The antimicrobial activity of secondary metabolites of halophilic bacteria against drug resistant microbes was assessed using the Agar well diffusion assay. Among the different extracts of the halophilic bacteria, the chloroform extracts of R. mannitolytica showed maximum antibacterial activity against Bacillus subtilis MTCC 441 and Xanthomonas campestris MTCC 2286. The results of antimicrobial activity are considerable because it enables the identification of potential secondary metabolites present in marine halophilic bacteria, which act as source of innumerable therapeutic agents. Further research is highly warranted to find out the active principle responsible for the antibacterial property and to elucidate the structure of particular compound.

134-143

Authors: Amal Kumar1*, Bhaswat S. Chakraborty2

Polychemotherapy and intermittent monochemotherapy regimens in metastatic breast cancer were examined in a meta analysis that included both tumor response rate and toxicities. Randomized controlled studies (conducted during 1990-2008) comparing monochemotherapy and poly-chemotherapy in advanced breast cancer patients were selected from electronic databases. Meta-analysis for response rate and toxicities [nausea and vomiting, toxic death, alopecia and reduced white cell count (WCC)] was performed using the Mantel-Haenszel method. The heterogeneity among the trials was assessed through a χ2 statistic, I2 and visual inspection of the forest plots. Analysis of eligible studies reveals statistical significant difference in response rate (OR 0.72, 95% CI 0.65-0.79), nausea and vomiting (OR 0.80, 95% CI 0.67-0.59), Alopecia (OR 0.75, 95% CI 0.64-0.88) and reduced WCC (OR 0.55, 95% CI 0.48-0.62) which favours polychemotherapy except toxic death (OR 0.87, 95% CI 0.58-1.29). There was marked evidence of heterogeneity in all end points except toxic death. This meta analysis shows the superiority of efficacy but not of safety of polychemotherapy over that of a single agent. However, the choice of treatment should be based on the response to the therapy, toxicity, patient preference, presence of metastases or imminent complications requiring aggressive and rapid tumor control.

149-152

Authors: Gopalakrishnan S1*, Vadivel E2

The bark of Bauhinia tomentosa L. is used wildly used for the treatment of varies ailments such as inflammation, wound, dysentery, skin diseases and for microbial infections. In the present study the ethanolic extract of the bark of Bauhinia tomentosa L. has been subjected to Gas Chromatography-Mass Spectrometry (GC-MS) analysis, while the mass spectra of the compounds found in the extract was matched with the National Institute of Standards and Technology (NIST) library. GC-MS analysis revealed the presence of fourteen phytochemical constituents, These compounds were identified by comparing their retention time and peak area with that of literature and by interpretation of mass spectra. The major chemical constituents are 4-(Benzyloxy)-1-methoxy-2-(3,7-dimethylocta-2,6-dienyl)-benzene (10.88%), Levodopa (6.39%) and (9E, 12E) - Methyl octadeca-9,12-dienoate (5.68%) which possess many biological activities. Hence these studies pave a platform to screen many bioactive components for wound healing.

157-165

Authors: Meetali M. Chaphekar*, Purnima D. Hamrapurkar

The concept of Quality by design (QbD) has recently gained importance in the area of analytical method development and involves understanding of the critical factors and their interaction effects by a desired set of experiments. So, the present work describes the development of Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method by QbD approach using Design of Experiments and subsequent validation for analysis of Vildagliptin in bulk drug and its pharmaceutical formulation. An efficient experimental design based on systematic scouting of all three key components of the RP‐HPLC method (Buffer pH, Organic Phase-% acetonitrile, Organic Modifier-Methanol) is presented. The significance and interaction effects of these parameters on the response variables (Retention time and tailing factor) were evaluated through statistical analysis tools like Analysis of Variance (ANOVA) and plots which revealed the final chromatographic conditions of the method. The developed method was validated and Forced degradation studies were also carried out in order to determine the stability-indicating nature of the method. The chromatographic separation was achieved on Jasco CrestPack RP C18 (250 × 4.6 mm, 5μ) column using Buffer (pH 6): Acetonitrile: Methanol (70:10:20 v/v) as mobile phase and detection was done using Photo-Diode Array (PDA) detector at 210 nm. The developed method of Vildagliptin is linear over a range of 5-15μg/ml having correlation coefficient R2 value as 0.999. The %RSD for precision and accuracy of the method was found to be less than 2%. Forced Degradation studies revealed that the method was found to be stability-indicating. The results showed that the proposed method is suitable for the precise and accurate determination of Vildagliptin in bulk and its formulation.

170-173

Authors: Vineeta V. Khanvilkar*, Rupali R. Kothekar

A simple, rapid and economic UV spectrophotometric method has been developed and validated using a solvent 0.1N HCl to determine Dextromethorphan hydrobromide content in bulk and two different pharmaceutical solid dosage formulations, lozenges and chewable tablets. At the pre-determined λmax of 278 nm, it was proved linear in the range of 5.0-30.0 µg/ml and exhibited good correlation coefficient (R2=0.9993) and excellent mean recovery (101.37-100.76%) and (100.66-101.17%) for lozenges and chewable tablets respectively. This method was successfully applied to the determination of Dextromethorphan hydrobromide content in lozenges and chewable tablets and the results were in good agreement with the label claim. The method was validated as per ICH guidelines for linearity, precision, accuracy, specificity, LOD and LOQ. The obtained results proved that the method can be employed for the routine analysis of Dextromethorphan hydrobromide in bulks as well as in the pharmaceutical formulations.

182-188

Authors: Bipul Nath*, Tushar Kanti Roy

The objectives of present investigation is to evaluate the compatibility of Atorvastatin calcium with immediate release excipients and to optimize the tablet which release is best comparable with innovator product by varying different super disintegrants. Various excipients used were sodium starch glycollate, cross carmellose sodium, cross-povidone, lactose, micro crystalline cellulose, mannitol, sodium lauryl sulfate, magnesium stearate, and stearic acid. Thermal characterization of the drug was done by DSC and FT-IR. From the DSC studies, the excipients such as microcrystalline cellulose (Avicel 101), magnesium stearate, mannitol, sodium lauryl sulfate were found to have physical interactions with Atorvastatin. Immediate release tablet was prepared by direct compression method and its release profile was compared with the marketed IR tablet. The prepared tablet have conform the pharmacopoeial limit for hardness, thickness, friability, weight variation and content uniformity. Formulation F11 containing two super disintegrants have shown the disintegration time less than 25 sec and better dissolution than all other formulations releasing more than 80% of the drug after 20 minutes. Kinetic data reveals that the drug release follows best order by Higuchi model, followed by korsemeyer peppas, zero order and first order mechanisms. The results of accelerated stability studies as per ICH guidelines indicated that the tablet was stable as there were no any significant physical changes after the study.

75-82

Authors: Mallikarjuna Gouda M1*, Ramakrishna Shabaraya A2

In the present investigation planned to study the less explored sterculia gum as matrix carrier of Budesonide to colon. Developed the formulations from B1 to B4 contains alone sterculia gum and its proportion increased gradually in the formulation. The formulations B5 to B10 contain the sterculia gum in combination with Eudragit S 100 and the hydrophilic, hydrophobic polymer. The budesonide core in coat matrix tablets was prepared by direct compression method. The powder bed of the formulations is evaluated for pre compressional characteristics like bulk density, tapped density, compressibility index and angle of repose. The compressed budesonide core in coat matrix tablets were evaluated for post compressional characteristics like thickness, diameter, hardness, disintegration, friability and to understand the drug release pattern and to correlate the in vivo condition, the in vitro dissolution performed in three different gastro intestinal pH at 1.2, pH 7.4 and pH 6.8 with and without 4% rat cecal content. The in vitro dissolution results of formulations ascertain that sterculia gum alone in formulation uncontrolled the drug release in first 5 hrs and carried lesser amount of drug to colon. The formulations B8 in the first 5 hours released 4.3% and carried the larger amount of drug to colon and in absence of rat cecal content released 90% and in presences of 4% rat cecal content released 99% of drug, indicating the sterculia gum undergoes enzymatic degradation and this formulation is considered as potential in targeting the budesonide to colon in the local ulcerative colitis.

87-90

Authors: Kamanashis Das1*, Md. Yasin1, Ishrak Jahan1, Tahira Akter1, Saiful Islam2, Md. Sagir Mia3

In order to prepare the sustained release tablet with levo-salbutamol sulphate we have used these excipients methylcellulose, PVPK30, magnesium stearate, talc, isopropyl alcohol, microcrystalline cellulose, lactose, HPMCK100, HPMCK4M. Here our approach was for making the sustained released matrix tablet by two ways, one is to make the tablet granules floating and the second one is by retarding the release of the levo-salbutamol sulphate from the matrix. We have already discussed the relationship with delaying the gastric transit time and the active drug absorption, if the tablet granules are floating in our introduction part. Since the above mentioned excipients are floating in nature so formulations with those excipients are supposed to be floating. We also showed a list of excipients those are used in the preparation of floating tablets. Now the second observation which was the release rate, among the three different formulations (mentioned in the introduction) we found different types of release. Since our objective is to prepare a sustained released tablet which will give a prolong release time, in that prospect two among the three formulations were disqualified (though we have not done the kinetic study). We observed desired effect in the formulation-2 during the preparation of experiment.

98-102

Authors: Krushnkumar Karangiya1*, Jatin Upadhyay2

In present study the new series of 3-(Aryl)-5-[4-(2, 4-Dichlorophenylmethoxy)-3-methoxyphenyl]-4, 5-dihydro pyrazoline (2a-k) and 3-(Aryl)-5-[4-(2, 4-Dichlorophenylmethoxy)-3-methoxyphenyl]-4, 5-dihydroacetyl pyrazoline (3a-k) derivatives were synthesized from various substituted 3-Methoxy-4-(2, 4-Dichlorophenyl methoxy) chalcones (1a-k). The new chalcones were synthesized using various acetophenones with newly synthesized aldehyde of vanillin analog by Claisen-Schmidt condensation. Characterization of pyrazoline derivatives have been established on the basis of IR, NMR, Mass and elemental analyses. The derivatives were screened for their in vitro antimicrobial Screening.

111-116

Authors: Mehul K. Bhatt1*, Nehal Shah2

Hygrophila salicifolia (Family: Acanthaceae) is an erect herb, nearly glabrous, mainly whole herb used as raw material in medicine. The aim of present investigation was to evaluate acute toxicity, in vitro urolithiatic and diuretic activity of methanolic extract of Hygrophila salicifolia, whole herb. Methanolic extract of Hygrophila salicifolia was administered to experimental rats orally at 2000 mg/kg p.o. The acute toxicity of the extract was evaluated as per OECD guideline 420. The LD50 of the extract was found to be between 2000-5000 mg/kg p.o. Urolithiatic activity was determined for all extracts using Conductometric titration and crystal growth inhibition. Methanolic extract of Hygrophila salicifolia was administered to experimental rats orally at doses 300 & 500 mg/kg p.o. Furosemide (10 mg/kg) was used as positive control. The diuretic potential of the extracts was evaluated by measuring urine volume, Diuretic index, Lipchitz value, Saliuretic index, Na+/K+ ratio and excretion of sodium-potassium content. The present study provided quantitative and qualitative basis for explaining non toxicity, urolithiatic and diuretic potential of methanolic extract of Hygrophila salicifolia.

121-127

Authors: Abhay R. Shirode*, Arpita P. Nath, Vilasrao J. Kadam

A new isocratic simple and rapid reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and successively validated for the estimation of ziprasidone hydrochloride monohydrate (ZHM). In this newly developed method chromatographic separation of ZHM was achieved on a Hemochrom-Intertsil C18-5U column (250 × 4.6) mm within a short runtime of 6.5min using mobile phase containing HPLC grade water (pH adjusted to 3.0 with glacial acetic acid AR) and methanol in the ratio of 45:55% v/v. ZHM was estimated with UV detection at 317nm and it was found to be eluted at 4.8min. The above mentioned method was validated as per International Conference on Harmonization (ICH) guidelines with respect to accuracy, precision, linearity, lower limit of detection (LOD) and lower limit of quantitation (LOQ) and robustness. The method was found specific for ZHM and linear (r2 =0.998) over concentrations ranging from 2 to12μg/ml. The method was found statically accurate (mean recovery = 100.46%), precise with both intra-day and inter-day relative standard deviation (RSD) values < 1.0% and robust. The obtained results concluded that the proposed RP-HPLC method is convenient, reliable and useful in routine analysis for estimation of ZHM in its bulk form and dosage form.