METHOD DEVELOPMENT AND VALIDATION OF SOLID DOSAGE FORM OF RIVAROXABAN BY RP-HPLC

The main objective of current study was to establish simple, sensitive, high-speed and precise RP-HPLC technique for the estimation of Solid Dosage form of Rivaroxaban as per ICH guidelines. Prospective experimental study conducted in the laboratories of Pharmaceutics, Faculty of Pharmacy, Hamdard University from January to September 2019. Study was carried out using LC Solution technology on Shimadzu HPLC LC-20. The separation was done by using Thermo Scientific Hypersil ODS 5 μ C18 column (4.6 x 250 mm) as a stationary phase. The mobile phase was prepared utilizing Buffer & Acetonitrile in the ratio of 700:300 (v/v) run at the flow rate of 1.0 mL/minute. The peak elution was observed at 6.177 mins at wavelength 250 nm when 10.0 mL was injected. The technique showed linear behavior in the range of 0.5% (0.101 mcg/ml) to 120% (24.139 mcg/ml) of test concentration with linear standard curve and correlation coefficient was found to be R2=0.999, peak symmetry for Rivaroxaban was excellent & the Limit of Detection and Limit of Quantification were found to be as 0.004 mcg/mL & 0.006 mcg/mL respectively. Current method was established and validated according to the ICH guidelines and all parameters were adjusted according to the US FDA designed Method Guidelines.