M. Siva Kumar Naik1, M. Devendra1, P. Mohan Babu1, B. Mohammed Ishaq1*,
E. Satheesh Kumar1, Hindustan Abdul Ahad1, Ramesh Dhani2
1Dept. of Pharmaceutical Analysis, Balaji College of Pharmacy, Anantapur–515001, A.P, India.
2Dept. of Pharmaceutical Chemistry, Ratnam Institute of Pharmacy, SPSR Nellore, Andhra Pradesh, India-524346
There are several generics of metformin hydrochloride tablets available within the drug delivery system globally. Availability of numerous brands of Metformin Hydrochloride tablets in Indian drug market today places health practitioners in a dilemma of generic substitution. The aim of the present study was the evaluation and comparison between ten different Metformin hydrochloride brands which are commercially available in the Indian market. The physicochemical equivalence of ten brands of Metformin hydrochloride tablets were determined through the evaluation of both official and non-official standards according to the Indian pharmacopoeia including uniformity of weight, friability, hardness, disintegration, dissolution rate and drug content (Assay) etc. All the brands complied with the official specifications for uniformity of weight, disintegration and dissolution tests. Few Brand had the highest and lowest crushing strengths. However, for the friability test, one of the ten brands failed to meet the Indian pharmacopoeia specification for friability. Seven brands had values within the range specified for assay in the IP while few brand failed the test. Of all the ten brands evaluated in this study, Indian government supply tablets could be regarded as being biopharmaceutically and chemically equivalent and therefore can be interchanged in the clinical practice.
Keywords: Metformin hydrochloride tablets, Indian pharmacopoeia, friability, hardness, disintegration, dissolution rate, Assay.