Development and Validation of Stability Indicating HPTLC Method for Estimation of Dasatinib and Characterization of Degradation Products by Using Mass Spectroscopy

[摘要] Dasatinib which is available in market as a brand name of Sprycel tablets. Method was validated according to the ICH guidelines. The HPTLC method was developed using Camag HPTLC system. Silica G60 F254 precoated TLC plates were used as stationary phase. Mobile phase was used toluene: methanol (6:4). Dasatinib analysis was carried out in the absorbance mode at 240 nm. The drugs were satisfactorily show peak with RF 0.65 ± 0.03 for Dasatinib. Development method was validated as per ICH guideline using validation parameter like specification, linearity, accuracy, LOD, LOQ, precision, and robustness. The method was found to be linear in the range of 200ng-1.2µg and correlation coefficient value 0.997.dasatinib. In stability testing, Dasatinib were found susceptible to alkaline degradation. Because the method could effectively separate the drugs from their degradation products, it can be used as a stability indicating method. Degradation product of Dasatinib in alkaline condition was carried out and its degradation product is successfully separated and isolated by HPTLC method. Degradation product was identified by using MS-MS technique.

[学科分类] 分析化学

[关键词] Dasatinib;HPTLC;stability indicating assay;isolation of degradation product;MS-MS identification