Stability-indicating analytical methods for pharmaceutically active substances-montelukast sodium, pioglitazone hydrochloride, florfenicol and ceftazidime pentahydrate

Abstract

The development of a suitable stability-indicating method was very important in the pharmaceutical drug development. As per the current International Conference of Harmonization (ICH) requirements the evaluation of stability samples must be carried out using stability-indicating analytical methods. A review of literature reveals a large number of methods reported over a period of 3-4 decades under the nomenclature of ?stability-indicating?. However, most of the reported methods fall short in meeting the current regulatory requirements.This subject or topic for the research activity is selected on the increasing needs of the pharmaceutical industry in developing suitable stability-indicating methods. Among the various other available techniques, the scope of work was focused on the stability-indicating techniques, which are very precise, accurate and sophisticated techniques are having wide spectrum of application in pharmaceutical industry. The development of stability-indicating analytical method and validation of such a chromatographic method needs a lot of theoretical study, practical knowledge, skill, capability of application, literature search, visualization of experimental and extrapolated results and assessing the right conditions for use, application andfinalization of method.Four different classes of active pharmaceutical ingredients (API?s) for research work keeping an objective to develop suitable stability-indicating analytical methods. Literature search reveals that no stability-indicating analytical methods for four selected API?s were available as on date. The research work carried out for thesis focuses on the development of stability-indicating analytical methods for some active pharmaceutical ingredients. The work also includes the validation of the developed methods as per ICH requirements and demonstrates the suitability of developed methods to assess the stability samples of API?sThe first chapter consist of brief Introduction and importance of stability-indicating analytical methods.