RP-HPLC method for analytical method development and validation of multi-kinase inhibitor

Abstract

This study was set out to create an RP-HPLC system that is effective, sensitive, picky, precise, accurate and practical. For this, a UV detection technique for detecting Sorafenib tosylate-loaded solid lipid nanoparticles has been developed and validated. To improve the procedure, many parameters were used (pH and Column). The chromatographic separation was carried out using a Shimadzu prominence-i LC-2030C and a C8 short column (5 m 4.6 x 100 mm). With a runtime of 10 minutes, 10 mL injection volume was maintained at 1 mL/min flow rate. The mobile phase used in the study was a mixture of 70:30 methanol:0.1% formic acid in water. The effluent was detected at 261nm using a UV detector. Drug Entrapment Efficiency (DEE) and Drug Loading (DL) for ST from the extracted SLNs matrix were found to be 86.9% and 19%, respectively. The developed analytical method exhibited a linearity range of 1-64g/ml and an R2 value of 0.998. 0.88 g/ml detection limit (LOD) and 1.0 g/ml limit of quantification (LOQ), and 0.88 g/ml detection limit (LOQ). Using ICH Q2(R1) guidelines, the proposed technique was evaluated, and it was shown to be accurate, linear, robust, and specific. Using the devised analytical method, drug release, drug loading, and drug entrapment effectiveness were all studied.