Development and Validation of Midostaurin Assay by RP-HPLC Method

Abstract

Midostaurin is a multi-targeted protein kinase inhibitor that has been used for the treatment of acute myeloid leukemia.  Here, a rapid and precise reverse phase high-performance liquid chromatographic method has been developed for the validation of midostaurin, in its API form as well as in capsule dosage form. Chromatography was carried out on a X-Bridge C18 (4.6 x 250 mm, 5 µm) column using a mixture of methanol: water (75:25% v/v) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 243nm and the retention time of the midostaurin was found to be 3.155. The method produce linear responses in the concentration range of 10-50 µg/mL of midostaurin. The method precision for the determination of assay was below 2.0 % RSD. The LOD and LOQ values obtained were 1.2 µg/mL and 3.8 µg/mL respectively. There were no significant changes observed upon changing chromatographic conditions indicating the method to be robust. Therefore this validated method can be useful in the quality control of bulk and pharmaceutical formulations of midostaurin.