In vitro evaluation of different brands of metformin Hydrochloride tablets available in Pokhara Valley.

Thesis Report.

ABSTRACT: In Nepal, 36 different brands of Metformin Hydrochloride tablets of 500 mg (milligram) are registered in Department of Drug Administration (DDA), Nepal including products from World Health Organization recommended Good Manufacturing Practice (WHOGMP) certified and non-GMP certified Nepalese pharmaceutical industries as well as imported brands. Prescribers are often in difficult situation to choose the ideal brand among various seemingly equivalent brands. Previous studies in Nepal on Albendazole and Pantoprazole indicated the risk of substandard drugs which evoked the necessity of pharmaceutical evaluation of different marketed brands. On the other side, India one of the major source for import of pharmaceutical products, claims the prevalence of substandard medicine in major Indian markets. The lifelong use of metformin, possible price variation, and risk of substandard drugs requires the detail study regarding the quality control parameter. Eight different brands including 3 Nepalese GMP certified, 1 Nepalese non GMP certified, 4 imported brands were taken under study. Pharmacopoeial quality control parameter viz. friability, weight and weight variation, dissolution and assay were carried out as per Indian Pharmacopoeia 1996 amendment II. Similarly non pharmacopoeial analysis such as hardness was analyzed. Thus, this study was conducted to evaluate the different brands of metformin in Pokhara valley in vitro. All the data are represented as Mean ± SD. The statistical analysis were done using SPSS version 17 for analysis of variance (ANOVA) at p value 0.05. Key words: Metformin, in vitro, pharmacopoeial, evaluation