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

Química Nova

Kumar, Poonam¹  Kumar, Avvaru Praveen¹  Park, Jung Hag¹  Reddy, Bobba Venkateswara¹  Haque, Syed Wasimul¹  Gautam, Haum Dutt¹  Reddy, Gosula Venkat Ram¹ 

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 work describes a novel stability-indicating reversed-phase ultra performance liquid chromatography method for the separation and quantification of rosuvastatin (RSV) and its related impurities in the pharmaceutical dosage forms under forced degradation conditions. An unknown degradation impurity detected in the acid degradation 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 impurities and degradation products were separated. The developed method was validated for RSV and related impurities in pharmaceutical dosage forms.

【 授权许可】

Unknown