Validation analytical methods for certain antidiabetic formulations

Abstract

Diabetes is a common disease affecting several million of individuals worldwide. This thesis describes the development of validated high performance thin layer chromatographic method for the estimation of charantin from bitter melon fruits and high performance liquid chromatographic methods for the simultaneous estimation of antidiabetic drugs in pharmaceutical formulations and plasma. newlineA simple, precise and accurate reverse phase high performance liquid chromatographic method has been developed and validated for the analysis of Miglitol in tablet dosage forms. The separation was achieved using C8 column at ambient temperature with a mobile phase consisting of sodium dihydrogen phosphate buffer: acetonitrile at a ratio of 85:15% v/v, pH 3.5 and flow rate of 1ml/min; with a retention time of about 3.40 minutes for Miglitol and 7.30 minutes for internal standard Voglibose. The method was linear at the range of 1-11and#956;g/ml and correlation coefficient was found to be 0.999. newlineMomordica charantia (Bitter melon) is used as a folk medicine, dietary supplement and sometimes concurrently used with drugs due to the presence of Charantin, one of the active constituent responsible for the hypoglycemic action. newlineA simple, sensitive high performance thin layer chromatographic method was developed for the determination of charantin in bitter melon fruits. The separation was achieved by using silica gel 60GF254 pre-coated plates with a mobile phase consisting of chloroform: methanol: water at a ratio of 1.5:6.0:2.5% v/v/v. The newlineii newlinemethod was linear at the range of 100-500ng/spot and correlation coefficient was found to be 0.999. The effect of Charantin content was studied in different cooking conditions. newlineA reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of four antidiabetic drugs namely Glibenclamide, Glipizide, Pioglitazone and Repaglinide in human plasma. Analysis was done by using C18 column with a mobile phase consisting of potassium dihydrogen phosphate buffer: acetonitrile