Development and Validation of Stability Indicating RP-HPLC Method for Rivaroxaban and Its Impurities

Rivaroxaban is oxazolidinone derivative having anticoagulant activity. In literature few analytical methods are discuss about estimation of rivaroxaban; but rarer discussion is available for rivaroxaban impurity profile. The objective of this study is to develop and validate RP-HPLC method for the qualitative analysis of Rivaroxaban. The chromatographic separation was achieved on ZorbaxSB C18 (250 mmX4.6 mm,3.5 μ) HPLC column using buffer (0.02M mono basic potassium di hydrogen phosphate) and solvent mixture (acetonitrile: methanol mixture) ingradient programme. The developed methods were validated as per ICH guideline and found to be specific, precise, sensitive and robust. Keywords: Rivaroxaban; oxazolidinone derivative; Anticoagulant drug, RP-HPLC method; related substance; impurity profil