DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR ESTIMATION OF RIVAROXABAN USING HPLC-PDA IN HUMAN BLOOD PLASMA
Rivaroxaban is oral anti-coagulant drug, used in the treatment of various blood disorders. A sensitive and accurate liquid chromatographic methodfor the quantification of rivaroxaban in human plasma was successfully developed. Protein precipitation was used for sample preparation. Quantification of analyte was achieved on phenomenexluna C8 (5Âµm x 25cm x 4.6mm i.d.) column using methanol:water:dimethyl sulfoxide (50:45:5, v/v/v) as mobile phase at a flow rate of 1ml/min. Detection was achieved at 252nm over the linearity concentration range of 5-40Âµg/ml. Retention time was found 6.2 min. The LOD and LOQ were found to be 1.5 Âµg/ml and 4.5 Âµg/ml, respectively.The developed method was validate as per US FDA guidelines.Â
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