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Abstract
The present paper describes stability indicating reverse phase Ultra performance liquid chromatographic (RPLC) assay method for Atrovastatin Calcium in bulk drugs. The developed method is also applicable for the related substance determination and degradation products generated from forced decomposition studies. The drug substance was subjected to stress conditions of acid hydrolysis, base hydrolysis, oxidation, photolysis and thermal degradation. The degradation of Atrovastatin was observed under acid hydrolysis, base hydrolysis and peroxide hydrolysis. The drug was found to be stable to other stress conditions attempted. Successful separation of the drug from synthetic impurities and degradation product formed under stress conditions was achieved on a C18 column using buffer 0.02 M phosphoric acid and acetonitrile. The developed UPLC method was validated with respect to linearity, accuracy, precision, specificity and ro-bustness. The developed UPLC method to determine the related substances and assay determination of Atrovastatin can be used to evaluate the quality of regular production samples. It can be also used to test the stability sample of Atrovastatin Calcium.
Highlights
The present paper describes stability indicating reverse phase Ultra performance liquid chromatographic (RPLC) assay method for Atrovastatin Calcium in bulk drugs
The degradation of Atrovastatin was observed under acid hydrolysis, base hydrolysis and peroxide hydrolysis
Atrovastatin is a synthetic hydroxyl methyl glutaryl coenzyme A (HMG-CoA) reductage inhibitor that has been demonstrated to be efficacious in reducing both cholesterol and triglyceride
Summary
Atrovastatin is a synthetic hydroxyl methyl glutaryl coenzyme A (HMG-CoA) reductage inhibitor that has been demonstrated to be efficacious in reducing both cholesterol and triglyceride. It is administered as the calcium salt of the active hydroxyl acid and is used to reduce the raised levels in patients with primary hyperlipidemia or combined hyperlipidemia [1,2]. Several LC-MS methods have been developed for quantification of Atv and its metabolites in plasma [8,9], Atrovastatin calcium and its impurities (Figure 1). Analyzed time is very less while comparative with all methods. The aim of the present study was to establish inherent stability of Atv through stress studies under a variety of ICH recommended test conditions and to develop a stability indicating assay [10]
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