Development and validation of analytical methods for estimation of some antihypertensive drugs

Abstract

Stability indicating chromatographic methods has been developed for some antihypertensive drugs Lisinopril Dihydrate, Felodipine and Cilnidipine. HPTLC method was developed for simultaneous estimation of Lercanidipine Hydrochloride and Enalapril Maleate in their laboratory mixture. HPTLC method was developed for the estimation of Azilsartan Medoxomil in its pharmaceutical dosage forms. newlineAll developed methods have been validated according to ICH guideline Q2 (R1) for specificity, linearity, range, precision, limit of detection, limit of quantification and accuracy. All methods were found to be linear with good correlation co-efficient. Validation data showed that each method is accurate, precise and specific for the estimation of corresponding Antihypertensive agent. newlineEach method was applied for the analysis of corresponding drug in its marketed formulation or its laboratory mixture. Assay results were found in good agreement with the content of API. newlineLisinopril Dihydrate, Felodipine and Cilnidipine were subjected to stress testing study for acid hydrolysis, alkali hydrolysis, oxidative degradation, photolytic degradation and thermal degradation and analysed by the developed method to check the stability indicating property of method. Each method resolves degradation products formed in various stress conditions from corresponding drug which indicates that each developed method possesses stability indicating property. newlineDegradation kinetics was also studied for Lisinopril Dihydrate in oxidative medium and Felodipine in alkaline medium at three different temperatures. Degradation of both the drugs was found to follow first order kinetics. Thus, all developed methods were found to be specific, accurate and precise for the estimation of corresponding drugs and can be used for routine analysis of drugs in their marketed formulations. newline