DEVELOPMENT OF VALIDATED STABILITY INDICATING HPLC METHOD OF CERTAIN DRUGS WITH IDENTIFICATION OF IMPURITIES USING LC MS

Abstract

Stability-indicating assay is a method employed for the analysis of stability samples in newlinepharmaceutical industry. With the advent of the International Conference on Harmonization newline(ICH) guidelines, the requirement for establishment of a stability-indicating assay method has newlinebecome mandated. The definition for stability-indicating methods in the draft guideline of United newlineStates-Food and Drug Administration (USFDA) 1998 reads as: Validated quantitative analytical newlinemethods that can detect the changes with time in the chemical, physical, or microbiological newlineproperties of the drug substance and drug product, and that are specific so that the contents of newlineactive ingredient, degradation products, and other components of interest can be accurately newlinemeasured without interference [1]. This statement implies that a stability indicating method is an newlineanalytical procedure capable of discriminating between the major active pharmaceutical newlineingredient/s (intact) from many degradation products formed under defined storage conditions newlineand can accurately measure the active ingredients, without interference from degradation newlineproducts, process impurities, excipients, or other potential impurities and can detect changes with newlinetime in the pertinent properties of the drugs. newlineA forced degradation study is an important part of the drug development process undertaken to newlinedemonstrate specificity when developing stability-indicating methods, particularly when little newlineinformation is available about potential degradation products. The deliberate attempt to stress the newlinedrug molecule under harsh conditions helps in evaluating the degradation pathways followed newlineunder a variety of stress conditions as laid in the ICH guidelines. Degradant and impurity profiles newlineare critical to the safety and potency assessment of the drug products for clinical trials. newlineTherefore, the identification of degradants in drugs has been of increasing importance in drug product assessment.