Abstract

DEVELOPMENT AND VALIDATION OF REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR QUANTITATIVE ESTIMATION OF MIDOSTAURIN IN CAPSULE DOSAGE FORM

Sayali Thakekar*, Bharti Fegade, Madhuri Jadhav, Dr. Vijaya Kumar Munipalli, Dr. Raman Mohan Singh and Dr. Vaidhun Bhaskar

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Abstract

A novel, simple, accurate, precise and reproducible RP-HPLC method was developed and avalidated for estimation of Midostaurin in bulk and capsule dosage form. Objective was under optimized chromatographic conditions on Thermo Scientific C18 Column (250 mm × 4.6 mm id, 5 μ) using mobile phase composed of water, acetonitrile and trifluroacetic acid in the ratio of (20: 80: 0.1%v/v). The separation was achieved using an isocratic method with flow rate 1ml/min at 300C. The effluent was monitored at 293 nm. The retention time was found to be 5.40 min. The method was linear over concentration range of 10-80 μg/ml with regression coefficient 0.9994. The developed method was validated as per ICH guidelines.

Keywords: Midostaurin, Validation, HPLC.