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

Abstract

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.