Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms

Quimica nova

关键词: UPLC-QToF-MS;    rosuvastatin tablets;    degradation study.;   

DOI  :  10.1590/S0100-40422011000200015

学科分类：化学（综合）

来源: Sociedade Brasileira de Quimica

【 摘 要 】

The present workdescribes a novel stability-indicating reversed-phase ultra performance liquidchromatography method for the separation and quantification of rosuvastatin(RSV) and its related impurities in the pharmaceutical dosage forms under forceddegradation conditions. An unknown degradation impurity detected in the aciddegradation was identified by using quadrupole time-of-flight mass spectrometry.The chromatographic separation was carried out on C-18 column (100 x 2.1 mm,1.7 μm)using isocratic elution with methanol and 0.1% trifluoroacetic acid (50:50).The total run time was 12 min within which RSV as well as all related impuritiesand degradation products were separated. The developed method was validatedfor RSV and related impurities in pharmaceutical dosage forms.

【 授权许可】

CC BY