Development andvalidation of new hplc methods for the quality control testing of some of the active pharmaceutical ingredients

Abstract

The proposed research work focuses on the development of new HPLC methods for the quality control testing of some of active pharmaceutical ingredients (API s). The proposed work also includes the validation of the developed methods as per International Conference on Horminaisation (ICH) requirements and demonstrates the suitability of developed methods not only to check the quality testing during its production but also to assess the stability of active pharmaceutical ingredient during stability studies. The development of a suitable validated stability-indicating HPLC method was very important for the quality control testing of the pharmaceutical drugs development. As per the current ICH and regulatory 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 for quality control testing of the drugs. However, most of the reported methods fall short in meeting the current regulatory requirements. To meet the regulatory requirements the methods should be specific validated and the method must be stability indicating. newlineFour different classes of active pharmaceutical ingredients (API s) namely Gatifloxacin, Moxifloxacin, Levofloxacin, and Amascrine were selected for research work keeping an objective to develop suitable validated stability-indicating analytical methods for their quality monitoring. Literature search reveals that no stability-indicating HPLC analytical methods for four selected newlineiv newlineAPI s were available as on date. Suitable novel stability-indicating HPLC methods were developed, keeping the current regulatory requirements in mind and the developed methods were extensively validated. The performance of the developed HPLC methods has been verified by applying the same to evaluate the quality of bulk samples of API during its production as well as their stability studies. The developed HPLC methods were performed well for the quality evaluation of stabil