Authors : Harish R. Pawar1*, Shubham N. Kanawade2, Tushar P. Dukre3, Salim G. Patel4, Vishwas B. Patare5, Sagar N. Kharde6, Atul R. Kulkarni7
DOI : 10.53555/ajbr.v27i4s.4336
Volume : 27
Issue : 4
Year : 2024
Page No : 3957-3973
The present study was designed to formulate and develop a analytical method for the metformin hydrochloride and amlodipine besylate as fixed dose combination bilayer tablet for treatment of type II diabetes mellitus and for hypertension. In the method development by RP-HPLC The retention time for metformine hydrochloride and amlodipine besylate was found to be 3.61 and 7.25 min respectively. Different formulation of sustained release layer of metformin hydrochloride was prepared by using HPMC K 100M and PVP K 30, immediate release layer was prepared using sodium starch glycollate and HPMC K 4M. Based on the in vitro dissolution data M6 and A6 was selected as the best formulation from metformin hydrochloride and amlodipine besylate formulations respectively. In vitro dissolution study of bilayer tablet was done in USP type II apparatus along with UV spectrophotometer gave % drug release of metformin hydrochloride as 97.819 at 16 hrs and amlodipine besylate as 96.303 at 30 min. From the study it was found that, HPMC K 100M shows good sustained release for 16 hrs and sodium starch glycollate shows good disintegration of immediate release layer.