Abstract
VALIDATED LC-MS/MS METHOD FOR THE DETERMINATION OF THREE GENOTOXIC IMPURITIES IN RIVAROXABAN DRUG SUBSTANCE

Vijaya Gouri Korlakunta*, Vijaya Bharathi Dasari, Hemant Kumar Sharma, Annapurna Nowduri, Kishore
Babu Bonige and Ramadas Chavakula

ABSTRACT

A simple and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for the determination of three potential genotoxic impurities in Rivoraxabin drug substance. LCMS/ MS analysis of these impurities was performed on Hypersil BDS C8, 5.0 μm, (100 mm×4.6 mm) column. This method was developed by using ammonium formate (0.639 g/Lt) as mobile phase- A and methanol as mobile phase B in isocratic mode with the flow rate of 0.5 mL/min. A mixture of water and acetonitrile was used as a diluent in the ratio of 20:80 v/v. This method was developed with the short run time of 12 minutes. This method is able to quantify these genotoxic impurities at very low levels.

Keywords: Rivoraxaban; Anti-coagulant drug; Genotoxic Impurities; LC-MS/MS; Validation.


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