Development and validation of stability indicating assay by HPLC method for estimation of Rivaroxaban


Author(s): BadroonT, J. Sreeramulu

A novel high speed, high resolution Reverse phase-HPLC method was developed for estimation of assay in Rivaroxaban drug substance. The separation of drug from the possible impurities was achieved in an Inertsil C8 column. Potassium phosphate buffer at pH 3.0 and acetonitrile mixture was selected as mobile phase. Flow rate and detection were kept at 1.0 mL/min and 250 nm respectively. Column compartment temperature was maintained at 40 °c and sample compartment temperature was kept at ambient. Mixture of buffer with acetonitrile was selected as sample diluent. The developed HPLC method was subjected to validation parameters; Precision, Specificity, Linearity, Robustness, Ruggedness were established as per the guidelines recommended by ICH. Stabilityindicating nature of the method was also performed by exposing the sample under various conditions like acid, base, peroxide and photo stability conditions. Using the method one can carry out the quantitative estimation of assay in Rivaroxaban drug substance, further the same method can be adopted for determination of related substances also.

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