Abstract

QUANTIFICATION OF TRACE LEVEL IMPURITIES IN ROSUVASTATIN CALCIUM AND IDENTIFICATION OF DEGRADATION IMPURITY BY MASS SPECTROSCOPY

V. Venkateswarlu*, K. Hussain Reddy and G. Ramireddy

Abstract

A novel stability indicating reversed phase ultra performance liquid chromatographic method was developed for the quantification of Rosuvastatin calcium and its impurities in bulk samples. The chromatographic separation was achieved on Acquity BEH C-18 100mm x 2.1mm, 1.7um column using 0.1% TFA: Methanol with the flow rate of 0.3mL min-1. The stress degradation study including acid, base, H2O2, humidity, thermal and photolytic conditions were performed on tablets powder of Rosuvastatin calcium as per International Conference on Harmonization (ICH) guidelines to show the stability-indicating capability of the method. Major degradation was found in acid stress condition and the observed degradation impurity was identified using water Q-tof mass spectrometer. % Assay was calculated for the stressed samples against the qualified working standard. The developed method was validated with respect to specificity, LOD, LOQ, linearity, accuracy, precison and robustness as per ICH guidelines.

Keywords: Rosuvastatin calcium, RP-UPLC stability indicating method, LC-MS.