Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND VITAMIN D3 BY HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM’

Pooja S. Soni*

.

Abstract

A high performance liquid chromatographic method was developed for the simultaneous estimation of Rosuvastatin calcium and Vitamin D3 in bulk and pharmaceutical dosage form. The separation was achieved by Cosmosil C18 (25cm x 0.46cm) column and Acetonitrile: Buffer, pH 5.0 (75:25) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 237 nm. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation. Retention time of Rosuvastatin Calcium and Vitmin D3 were found to be 6.000 min and 4.473 min respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Rosuvastatin Calcium 25-75 μg/ml and for Vitmin D3 25-75 μg/ml. Precision was found less than 2% RSD and Accuracy was found to between 98.61- 100.77%.

Keywords: Rosuvastatin Calcium, Vitmin D3, simultaneous estimation, RP-HPLC.