Development and Validation of an HPLC Method for the Determination of Dasatinib from Self-micro Emulsifying Drug Delivery System

Abstract

Abstract The development of a novel reverse-phase high-performance liquid chromatographic method for the detection of dasatinib, an anticancer drug, in bulk and a self-micro emulsifying drug delivery system has been according to the guidelines provided by the International Council for Harmonization Q2 (R1). However, researchers developed a method to quantify API dasatinib and dasatinib from many formulations like tablets, and small-volume parenterals but in this proposed work dasatinib is quantified from the self-micro emulsifying drug delivery system by novel method. This method is characterized by its simplicity, precision, and cost-effectiveness. The maximum wavelength (λ max) of Dasatinib was determined to be 324 nm. The mobile phase consisted of a mixture of Methanol and 0.1% Tri-Fluro acetic acid in a volumetric ratio of 55:45. The flow rate was set at 1.0 mL/min. The method was developed using a C18 column, namely the Agilent Zorbax SB-Aq with dimensions of 250 x 4.6 mm and a particle size of 5µ. The RP-HPLC method exhibited linearity, as evidenced by a high correlation coefficient of 0.9993. The accuracy evaluations of the reversed-phase high-performance liquid chromatography (RP-HPLC) method were conducted at three distinct levels, namely 80%, 100%, and 120%. The recovery of Dasatinib within these levels ranged from 98% to 101%, with a relative standard deviation (% RSD) of 0.73%. The method employed in this study demonstrated stability and robustness under various testing parameters. The Limit of Detection (LOD) and Limit of Quantification (LOQ) were determined to be 0.17 ug/ml and 0.50 ug/ml, respectively, for the RP-HPLC method. Forced degradation is employed to assess the stability-indicating properties of an assay through the use of specificity. The results of the validation parameters were found to be within the range recommended by the International Council for Harmonization (ICH). The methodology employed in this study demonstrated a high level of accuracy, precision, and cost-effectiveness, making it a viable approach for future research endeavors. This technique is employed for the quantification of bulk medicines and the determination of dose forms containing self-micro emulsifying drug delivery systems.