New stability indicating chromatographic methods for desloratadine, clopidogrel, duloxetine, ibuprofen, diphenhydramine, losartan, atenolol and hydrochlorothiazide drugs

Abstract

In this thesis we provide new analytical methodologies UPLC/HPLC that can be improves the analysis throughput and cycle times. The proficient research work has been divided in to six chapters, The thesis is composed of five articles, eight active pharmaceutical ingredient (API) and five of their dosage forms were selected for the research work, keeping objective to develop a new stability indicating analytical methods for the determination of assay and related components which are stability indicating analytical methods. After through literature survey reveals that no stability indicating methods for determining the related process bi-products / impurities in the above mentioned eight selected API?s, its precursors and their dosage forms were available as on date, very few methods appeared in the literature for the determination of human plasma, Urine, LCMS/MS etc. Suitable new, simple, cost effective (user friendly) and stability indicating analytical methods were developed, keeping the current regulatory requirements in mind and the developed methods were extensively validated. The developed new analytical methods were performed well for the quality evolution of stability samples of API and its procuresses.The first chapter consists of a brief introduction on the need for development of new analytical methods for related components estimation, source of impurities in pharmaceutical substances, requirement for control of impurities, ICH quality guidelines,pharmacopeial norms, control of organic impurities, FDA recommendations, approaches for development of stability indicating methods with LC contents of method validation parameters and discussion on how to develop a new method approaches on the general methodology for LC (HPLC/UPLC) analysis. The remaining chapter 2-6 consists of Introduction, experimental, validation and results and discussion. In the introduction part a brief account on the therapeutic activity, drug molecule and need to developing new method development were discussed.