Asian Journal of Pharmacy and Technology

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Base Degradation Study and Method Development 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).The Drug was subjected to base degradation. The method was found to be robust and suitable for routine analysis of Rivaroxaban. Degradation products resulting from the stress studies did not interfere with the detection of Rivaroxaban and the method is thus stability-indicating.

Keywords

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

Abstract Views: 1908  |  PDF Views: 6

Authors

Pinaz A. Kasad
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).The Drug was subjected to base degradation. The method was found to be robust and suitable for routine analysis of Rivaroxaban. Degradation products resulting from the stress studies did not interfere with the detection of Rivaroxaban and the method is thus stability-indicating.

Keywords


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

References