CHEMOMETRIC ASSISTED METHOD DEVELOPMENT AND VALIDATION OF ROSUVASTATIN USING RP-HPLC

Abstract

The present work is based on the application of RP-HPLC determination of active substances of rosuvastatin by chemometric
assisted method development and validation Rosuvastatin is an Anti-hyper lipidemic agent. Symmetric c18 column (150mm x
4.6 ,3.5µm) was used to perform the chromatographic separation. Mobile phase was used in the ratio of 40:60v/v 1ml TEA in
1000ml water and acetonitrile. The flow rate was set at 1ml/min at ambient temperature with detecting wave length at 247nm.
Linearity was observed over the concentration range of 10-200 µg/ml for Rosuvastatin. Correlation coefficient was found to be
0.999 for Rosuvastatin drug. Percentage recovery values of pure drug were found to be 100.1% for Rosuvastatin Different
stress condition such as acidic, basic, oxidative, temperature (450C) and hydrolysis degradation studies were performed for
Rosuvastatin. HPLC method in combination with Chemometric calibration reduces errors in chromatographic analysis and
satisfy the limits of ICH guidelines.