Development and validation of chromatographic methods for the determination of drug substances, impurities and residual solvents by RP-HPIC/GC

Abstract

The purpose of this study was to develop and validate chromatographic methods to characterize pharmaceutical drug substance/product in terms of potency/purity, impurities, solubility, stability, and ionization constant. Reverse phase-high performance liquid chromatography (RP-HPLC) technique was mainly employed to develop and validate all chromatographic methods. Chapter I, of the thesis contains three parts which are introduction, analytical method development and analytical method validation based on RP-HPLC. Chapter II, therefore, describes the characterization of a novel anti-malarial drug lead Cyclen Bisquinoline using RP-HPLC methods. Chapters III and IV describes a development and validation of RP-HPLC stability indicating assay and impurity test method for non pharmacopoeial products, Aceclofenac Tablet and Salmeterol Inhaler dosage forms, respectively. All the RP-HPLC methods developed and validated to determine the content and related substances in the pharmaceutical tablets dosage form is specific, precise, linear, accurate, and rugged enough, which can be used in research and development and in quality control laboratories in pharmaceutical industries. Methods developed for novel anti- malarial drug lead Cyclen Bisquinoline would be useful in implementing the modern Quality by Design (QbD) approaches for further development of the drug leads to characterize their purity, stability, metabolic stability, solubility and ionization constant.