INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES

324-330

Authors: Vykuntam Uppala, N. Divya, E. Charishma, K. Harshavardan, Shyamala. M

A simple, Precised, Accurate method was developed for the estimation of Ibrutinib by RP-HPLC technique. Chromatographic conditions used are stationary phase Kromosil150mm x 4.6 mm, 5 ,Mobile phase0.1% OPA: Acetonitrile in the ratio of 40:60and flow rate was maintained at 1ml/min, detection wave length was 296nm, column temperature was set to 30oC and diluent was mobile phase Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R2 value was found to be as 0.999. Precision was found to be 1.01 for repeatability and 1.50 for intermediate precision. LOD and LOQ are 0.394µg/ml and 1.194µg/ml respectively. By using above method assay of marketed formulation was carried out 100.55% was present. Degradation studies of ibrutinib were done, in all conditions purity threshold was more than purity angle and within the acceptable range. Key Words: HPLC, Ibrutinib, Method development. ICH Guidelines.

340-347

Authors: Dr. Ananda Kumar, P. Renuka, K. Ashok Babu, K.V.S.L Prasanna, V. Rajya Lakshmi

The Chronopharmacotherapy the drug administration is synchronised with circadian rhythms Formulation development of Microspheres is more reliable formulation as compare to single type dosage formulation due to it avoids dose dumping, as per required drug release profile is achieved For microspheres many polymers are used such as albumin, gelatine, starch, Eudragit, Polyacrylamide (“PAM”) these material loading capacity is high. Micro sponges which are Spherical are called as micro-balloons. Due to its hollow structure it shows good floating properties. In these systems use of Carbon-dioxide (CO2) as gas generating system which are used for floating purpose. The objective of present investigation is to prepared and evaluate a floating pulsatile drug delivery system of Aceclofenac. The strategy adopted for microspheres containing Aceclofenac as a material were prepared by emulsion solvent diffusion technique. Drug and polymer were mixed in dichloromethane and ethanol at 1:1 ratio. The drug and polymer solution were poured in water 50% W/V polyvinyl alcohol maintained at 30-40 C and the solution was stir at 500rpm using mechanical stirrer, The microspheres obtain were washed repeatedly with water until free from poly vinyl alcohol. The developed formulations were evaluated yield of floating microspheres particle size and shape, drug entrapment efficiency in-vitro evolution of floating ability, in-vitro drug release study. On the basis of these evolution parameters it was found that optimised floating pulsatile release formulation F7 showed higher drug entrapment efficiency floating time 6.8 minutes and the drug and polymer 32 1:3 ratio the particle size was increased. Key Words: Chronopharmacotherapy, Floating pulsatile drug delivery, Aceclofenac.

351-357

Authors: P. Shaniya, NJR. Hepsebah, MD. Khasim, A. Ashok Kuma

The article aims at developing simple dissolution method for Eplerenone immediate release tablets by UV spectroscopy and validate as per ICH guidelines. The optimized dissolution method includes 0.1N HCl as dissolution media, apparatus as USP Type 2 Paddle, rpm as 100, temperature of dissolution media as 37±0.5ºC, dissolution volume as 500ml, dissolution time point as 1 hour, working concentration of standard and sample as 10µg/ml and a detection wavelength of 245 nm.The developed method resulted in Eplerenone exhibiting linearity in the range 2.5-20μg/ml. System precision and intra-day precision are exemplified by relative standard deviation of 0.695% and 0.933% respectively. Method was found to be rugged/inter day precise as %RSD was found to be 1.507%. Percentage Mean recovery was found to be in the range of 90-110 % by absolute method during accuracy studies. Hence it can be concluded that effective dissolution method by UV spectroscopy is developed and validated which can be applicable in various pharmaceutical industries. Keywords: Eplerenone, Dissolution method, UV, Validation.

368-373

Authors: Patel Nidhi1*, Patel Sweta1 , Jain Hitesh1 , Upadhyay Umesh1

Osmotically controlled oral drug delivery systems utilize osmotic pressure as energy source for the controlled delivery of drugs. The aim of the present study is to formulate and evaluate controlled porosity osmotic tablets of Losartan Potasssium. Losartan Potassium is used in hypertension. Core tablets were prepared by direct compression technique using mannitol, fructose and NaCl as osmogens and Avicel PH101 as filler. The osmotic tablet contains pore forming water soluble additives in the coating membrane, which dissolve after coming in contact with water, resulting in formation of an in-situ micro porous structure. The core tablets were coated by dip coating using cellulose acetate as a coating agent with PEG 400 and PEG 6000 as water soluble pore former and dibutyl pthalate as plasticizer. The formulations were evaluated for precompression and postcompression parameters. The batch F8C2 containing Fructose as an osmogen and 20 % PEG 6000 as a pore forming agent showed the 91.25 % drug release for 12 hrs. Keywords: Antihypertensive, Losartan Potassium, Osmotic, PEG 6000, Semi Permeable Membrane.