Abstract

A NOVEL STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF ROSUVASTATIN AND ROSUVASTATIN RELATED SUBSTANCES IN ROSUVASTATIN CALCIUM TABLETS

Sarath Nalla*, Lakshmi Kameswari Kavuri and Vijetha Pendyala

ABSTRACT

A rapid and sensitive stability indicating high performance liquid chromatographic (HPLC) method was developed for the estimation of rosuvastatin and its related substances in rosuvastatin calcium tablet dosage form. The present paper describes the development and validationof a stability-indicating HPLC for the estimation of known related substances in rosuvastatin calcium tablets. The chromatographic separation was achieved using a Waters XBridge BEH C8, 5μ, (250 mm x 4.6 mm) column. Mobile phases containing a gradient of ammonium acetate in water pH adjusted to 6.0 and a mixture of acetonitrile, tetrahydrofuranand water in the ratio of 750:200:50 v/v. was used. Peak purity of the rosuvastatin calcium was studied under various degradation stress conditions. Forced degradation studies on the formulation were conducted by adopting the proposed method to assess the stability of the analytes under acid, base, peroxide, thermal and photolytic conditions and suitability of the method to resolve the degradation products. The detection was done at 240 nm. The method was validated with respect to linearity, precision, sensitivity, accuracy, specificity, robustness.

Keywords: Rosuvastatin calcium tablets, Stability-indicating methods, HPLC, Method development, and Validation.