Development of Newest Analyticalchromatographic Methods for Determining Chosen Drugs And Impurities_ Stress Degradation Studies

Abstract

Drug is a substance which heals, cures the diseases in humans or animals. It is playing an important role in curing the diseases. After the discovery of penicillin, it acted as a new gate in developing novel drugs. The method development and validation is playing a vital role in 20th century in time reduction of discovery of drug and analysis. Depending on the toxicological concern the quality of the drugs should be assured by the guidelines releasing by Indian Pharmacopoeia. Impurities in drugs are the major reason for the toxic nature of drug. These impurities may be present in drugs as starting material, intermediates or as byproducts. These impurities should be separated from the drug in the final stage according to toxicological concern value given by ICH. newlineIn this context analytical chemistry is playing a significant role for method development by using instrumental methods. Among these methods HPLC is easy to perform in quality and quantity assurance of drugs. ICH releases guidelines to pharma industries for Development of method and validation. LC-MS and UPLC-MS are the newly developed methods whose principles are same as that of HPLC while differing only in the buffer preparation for mobile phase .The Analytical method development should be precise, accurate, and reliable for the separation and identification of impurities in drugs as per USP Guidelines. newlineSpecificity, accuracy, precision, linearity, LOQ, LOD etc... , are the validation parameters as per IUPAC. By using the above parameters the developed method should be validated newlineChapter-1: In this chapter, a general introduction to drug and analytical approaches such as HPLC techniques were discussed. newlineChapter-2: In this chapter we successfully determined the Genotoxic impurity GTI-A, in atzanavir sulphate by using LC-MS method. Atzanavir sulphate (ATS) is an antiretroviral drug. GTI- A is the Chemical Substance used for the preparation of ATS. This impurity has some toxicological property.