Development and Validation of Chromatographic methods for drugs i.e., Darifenacin, Zolpidem, Palonosetron and Intermediates to study the Impurity Profiles

Abstract

Determination of impurity profile for pharmaceutical compounds has a great importance while evaluating safety and efficacy of the drug product. In order to determine the impurity profiles, analytical testing of pharmaceutical compounds by means of suitable analytical techniques is newlinerequired. The thesis discusses the role of chromatographic techniques and need for the development of stability indicating analytical methods. The thesis also describes the current challenges in the chromatographic newlinemethod development and re-emphasizes the advantages of systematic method development approaches. Specific separation problems are newlineillustrated by selecting typical molecules that possess a variety of separation issues. The methodology further describes the way forward to resolve such separation problems. The method development activity newlinemainly focuses on the selection of suitable stationary phases and systematic optimization of chromatographic conditions. The specificity of the developed analytical methods is demonstrated by analyzing forced newlinedegradation samples and evaluating the spectral homogeneity of the compounds. In addition, possible degradation pathways are established based on LCMS analysis of the degradation impurities.