DEVELOPMENT AND VALIDATION OF CHIRAL HPLC METHOD FOR QUANTITATION OF ENANTIOMER IN ROSUVASTATIN CALCIUM

Abstract

A new, simple, precise, rapid and accurate normal phase enantioselective high performance liquid chromatographic method was developed for enantiomeric resolution of Rosuvastatin, which is used for the treatment of hypercholesterolemia. This is a fourth highest selling drug in the United States, accounting approximately $5.2 billion in the year of 2013. The enantiomer of Rosuvastatin and lactone impurity of Rosuvastatin were resolved on a CHIRALPAK IB (250 x 4.6mm, 5?m) column using a simple mobile phase system containing nheptane, 2-propanol and trifluoroaceticacid (85:15:01v/v). The resolution between Rosuvastatin and enantiomer, Rosuvastatin and lactone impurity was good with resolution factors more than 2.0 and 4.0, respectively. The effect of organic modifier, namely 2-propanol in the mobile phase was optimized in order to obtain the best separation.
The Limit of Detection and Limit of Quantitation of enantiomer were found to be 0.07?g/mL and 0.2?g/mL, respectively, for 10?L injection volume. The sample solution and mobile phase were stable for at least 48 hours. The proposed reproducible and accurate method can be useful for quantification of enantiomer of Rosuvastatin in the bulk drug substance.