Development and validation of a stability-indicating UPLC method for rosuvastatin and its related impurities in pharmaceutical dosage forms
| Autor: | Gosula Venkat Ram Reddy, Bobba Venkateswara Reddy, Syed Wasimul Haque, Haum Dutt Gautam, Poonam Kumar, Avvaru Praveen Kumar, Jung Hag Park |
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| Jazyk: | English<br />Spanish; Castilian<br />Portuguese |
| Rok vydání: | 2011 |
| Předmět: | |
| Zdroj: | Química Nova, Vol 34, Iss 2, Pp 250-255 (2011) |
| Druh dokumentu: | article |
| ISSN: | 1678-7064 0100-4042 |
| DOI: | 10.1590/S0100-40422011000200015 |
| Popis: | 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. |
| Databáze: | Directory of Open Access Journals |
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