Development and Validation of a Stability-Indicating RP-UPLC Method for Determination of Rosuvastatin and Related Substances in Pharmaceutical Dosage Form

摘要

A stability-indicating reversed phase ultra performance liquid chromatographic (RP-UPLC) method was developed for the determination of related substances in rosuvastatin calcium (ROSV) tablet dosage form. The chromatographic separation was achieved on an Acquity BEH C18 (100 mm × 2.1 mm, 1.7 μm) column with mobile phase containing a gradient mixture of solvent-A (0.1% trifluoroacetic acid) and solvent-B (methanol). The eluted compounds were monitored at 240 nm and the run time was 10.0 min. Degradation behavior of the ROSV was studied under various degradation stress conditions. Four major unknown degradation products (late eluting impurities) were found in acid stress condition and two unknown degradation products were found in oxidative stress condition. The developed method separates (six) unknown impurities, (three) known impurities and ROSV substance from each other, providing the stability-indicating power of the method. The developed RP-UPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. The developed and validated RP-UPLC method is LC-MS compatible and can be applied for identification of eluted unknown impurities of ROSV.