Asian Journal of Pharmaceutical Analysis

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Method Development and Acid Degradation Study of Rivaroxaban by RP-HPLC in bulk


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1 Shree Dhanvantary Pharmacy College, Department of Quality assurance, Kim, Surat, India
     

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A simple, precise and accurate HPLC method has been developed and validated for assay of Rivaroxaban. An isocratic separation was achieved using a phenomenex C18(250×4.6 mm, 5μm),100°A particle size columns with a flow rate of 1 ml/min and using a PDA detector to monitor the elute at 250 nm. The mobile phase consisted of Methanol: Acetronitrile (50:50, v/v). The method was validated for specificity, linearity, precision, accuracy and robustness. The method was linear over the concentration range of 20-100 μg/ml (r2= 0.99995). Intraday system and method precision were determined and accuracy was 99.89 %. The method was found to be robust and suitable for assay of Rivaroxaban in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Rivaroxaban and the assay is thus stability-indicating.

Keywords

Rivaroxaban, Oral Anticoagulant, 250 nm, Stability Indicating Method, Acid Degradation
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  • Method Development and Acid Degradation Study of Rivaroxaban by RP-HPLC in bulk

Abstract Views: 641  |  PDF Views: 3

Authors

A. Kasad Pinaz
Shree Dhanvantary Pharmacy College, Department of Quality assurance, Kim, Surat, India
K. S. Muralikrishna
Shree Dhanvantary Pharmacy College, Department of Quality assurance, Kim, Surat, India

Abstract


A simple, precise and accurate HPLC method has been developed and validated for assay of Rivaroxaban. An isocratic separation was achieved using a phenomenex C18(250×4.6 mm, 5μm),100°A particle size columns with a flow rate of 1 ml/min and using a PDA detector to monitor the elute at 250 nm. The mobile phase consisted of Methanol: Acetronitrile (50:50, v/v). The method was validated for specificity, linearity, precision, accuracy and robustness. The method was linear over the concentration range of 20-100 μg/ml (r2= 0.99995). Intraday system and method precision were determined and accuracy was 99.89 %. The method was found to be robust and suitable for assay of Rivaroxaban in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Rivaroxaban and the assay is thus stability-indicating.

Keywords


Rivaroxaban, Oral Anticoagulant, 250 nm, Stability Indicating Method, Acid Degradation

References