Abstrakt

Avalidated, stability indicating,LCand assaymethod for rosuvastatin

Ch.Krishnaiah, M.Vishnu Murthy, B.J.Durga Prasad, B.Satyanarayana, Ramesh Kumar , K.Mukkanti

A simple, gradient, stability indicating, reversed phase high performance liquid chromatographic method (LC) has been developed for the quantification of rosuvastatin and its related substances and of degradation products generated by decomposition. When rosuvastatin was subjected to acid hydrolytic, oxidative, photolytic and thermal stress, degradation was observed. Chromatographic separation was achieved among rosuvastatin and related substances and degradation products, which were obtained from stress conditions like acid, base, water hydrolysis and oxidation. The optimized conditions are there by using a step wise gradient elution mode on a C18 column using a mixture of 0.02 M Potassium dihydrogen orthophosphate, pH adjusted to 3.0 and acetonitrile in the ratio of (80:20) (v/v) as solvent-A and further using a mixture of acetonitrile and water in the ratio (90:10) (v/v) as solvent-B. Themethodwas completely validated in terms of linearity, accuracy, precision, specificity and robustness. The method can be used for quality control during manufacture and for assessment of the stability of samples of rosuvastatin. The LOD and LOQ values of rosuvastatin, rosuvastatin lactone and rosuvastatin ester are 0.05, 0.075, 0.077gmL-1and 0.2, 0.30, 0.31 gmL-1 respectively. The present RPLC can be able to determine rosuvastatin and its related substances simultaneously in bulk drug and finished dosage forms of rosuvastatin.