Development and Validation of a Robust RP-HPLC Method for Quantifying Dasatinib in Self-Microemulsifying Drug Delivery Systems.

Dasatinib, a therapy for chronic myeloid leukemia, suffers from poor bioavailability. Self-microemulsifying drug delivery systems (SMEDDSs) are used to improve its dissolution. This study aimed to develop and validate a novel reverse-phase high-performance liquid chromatography (RP-HPLC) method for quantifying dasatinib in SMEDDS formulations. The RP-HPLC method utilized a mobile phase of methanol and 0.1% trifluoroacetic acid (55:45, v/v) and identified a peak wavelength for dasatinib at 324 nm. SMEDDS formulations comprised Capryol 90, Transcutol HP, and Tween 40. The method was validated according to ICH guidelines, demonstrating excellent linearity (R 2 = 0.9993), accuracy (recovery between 98% and 101%), and precision (relative standard deviation of 0.73%). It also showed stability and reliability with limits of detection and quantification of 0.17 and 0.50 µg/mL, respectively. This RP-HPLC method meets all validation criteria and provides a robust, cost-effective tool for analyzing dasatinib in SMEDDS formulations.