Development and validation of chromatographic analysis of related substances of novel anti diabetic drugs

Abstract

Present work comprises of nine major chapters, which begins with introductory part and literature survey is followed by Method development and Method validation of Reverse Phase HPLC chromatographic method. newlineResearch work includes RP-HPLC technique for estimation and detection of different impurities present in Active Pharmaceutical Ingredients or may be generate during formulation preparation or during storage of formulation. Research work includes different trials taken on different mobile phases and different stationary phases to separate different impurities. Methods are also specific and selective for detection and quantifying impurities at LOQ to 150% of specification level. newlineImpurities or Related substances in pharmaceuticals which are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during stability testing, or develop during formulation or upon aging of both API and formulation. A simple and very sensitive methods developed for estimation of impurities present in anti diabetic drugs formulations by Reverse Phase High Performance Liquid Chromatographic method. newlineMethods are capable to detect impurities in very low level (1µg/mL). Above mentioned all methods were validated for the parameters like linearity and range, precision, accuracy, limit of detection and quantification, robustness, specificity, solution stability, force degradation study according to the ICH Q2R1 guideline. newline newline