Method Validation for Analysis of Drug Combination of Metformin Hydrochloride and Glebinclamide

Abstract

In this thesis the combination of metformin hydrochloride and glibenclamide drug used for diabetes mellitus type II, it was analyzed by developed method using simpleisocraticReverse phase high performance liquid chromatography (HPLC)with ultraviolet (UV)detector, mobile phase consist of acetonitrile and monobasic sodium orthophosphate (adjust to pH 2.5 by orthophosphoric acid) (50:50 V/V) with flow rate 1ml/minat 228nm.The drug combination wasdetermined according to the accepted worldwide verification standards. The proposed method was investigated according toInternational Council for Harmonization (ICH) guidelines and the characters showed simple, reliable, fast, accurate, linear, precise and low cost with relative stander deviation RSD less than 2%. The method was applied on finish product of different companies and the assay was determined.The results obtained agreed wellwith the pharmaceutical specification with good accuracy and it can be used in routine quality control analysis.