RP-HPLC method development and validation for the estimation of midostaurin in Bulk and pharmaceutical dosage form

Abstract

An elementary, Valid, speedy and decisive strategy was developed to determine Midostaurin quantitatively in a fixed dosage form. Effective Chromatographic separation of Midostaurin was achieved by using Hypersil C18 Column (250 mm X 4.6 mm internal diameter, five µm particle size) using a mobile phase composed of Methanol and Buffer in the proportion of 75:25(by vol-ume). The Mobile phase was siphoned using a gradient HPLC system at a flow rate of 1.0 ml/min, and quantification was based on peak area measure-ment at 270 nm. RT (Retention Time) for Midostaurin was 2.142 min, and dimensionality of Midostaurin was found to be linear with a statistic value of 0.999. The acceptance criteria of precision were relative variance should be less than 2.0%, and also the strategy showed precision 0.3 for Midostau-rin, which shows that the tactic was precise. The full Recovery was found to be 99.96 %. Detection Limit and Quantitation Limit values for Midostaurin were found as 0.439 & 1.466. The exactness and authenticity were assessed by evaluation of validation parameters like linearity, precision, specificity, accu-racy, LOD, LOQ values as per ICH guidelines. The proposed strategy has been applied to the formulation without additives interference and specific for the estimation of Midostaurin.