Development and Validation of RP-HPLC Method for the Determination of Sorafenib Tablet

Abstract

Sorafenib, an oral multi-kinase inhibitor, is an extensively utilized in oncology for its antineoplastic Department ofPharmaceutical Chemistry, Maharshi Arvind College of Pharmacy, Ambabari, Jaipur-302039, Rajasthan, India properties. Accurate quantification of Sorafenib in pharmaceutical formulations is critical for quality control and therapeutic efficacy. Reverse phase high-performance liquid chromatography offers a sensitive, rapid, precise, accurate high-performanceliquid chromatographic method for the estimation of Sorafenib (SOR) in the tablet dosage form. Chromatographic separation of SOR was carried out utilizing thermo-scientific model C18 column (4.6 mm i.d. X 250 mm; 5µm particlesize) (based on 99.99 % ultra-high purity silica) using mobile phase that consisting of acetonitrile: methanol (40:60 v/v) ata flow rate of 1.0 mL/min. The absorption maximum (λmax) of SOR in the mobile phase was found to be 266 nm. It had a retention time of 3.222 min. The calibration curve was in linear function of the drug in the concentration range of 2-10 µg/mL (r2 = 0.999) for the optimized method. The regression equation for SOR was found to be Y = 68228 x + 8071. The Detection Limit (DL) & Quantitation Limit (QL) results of SOR were found to be 0.525 µg/mL and 1.595 µg/mL respectively. The developed method was validated in pursuance of ICH Q2 (R1) guidelines. The method was linear, precise, accurate with recoveries in the range of 98 - 102 %, and minimum values of % RSD indicate the accuracy of themethod. The detailed quantitative results of the study show that this method is robust, precise, accurate, and cost-effective.Thus, the developed RP-HPLC method is reproducible and demonstrating its suitability for routine analysis of Sorafenib in pharmaceutical formulations.
Keywords: Sorafenib, RP-HPLC, Pharmaceutical formulation, Validation.