(RP- HPLC)Method Development and Validation of Dabrafenib in Capsule Dosage Form

Abstract

A rapid, sensitive and specific RP-HPLC method was developed for the determination of Dabrafenib in Capsule dosage form.Chromatographic analysis was carried out on Thermo Synchronis C18 column (25cm × 4.5 mm & 5 μ), using a mobile phase composed of  Phosphate buffer: Acetonitrile (ACN) (25:75) % v/v . Analysis was performed at 223 nm detector wavelength with 20µl of injection volume and 1.0 ml/min of flow rate with column temperature was kept at 25⁰C.Retention time was observed as 5.377min.The method was linear over the range of 10 to 70 µg/ml with linear regression coefficient (r²) 0.9995. The HPLC method was validated as per ICH guidelines. This developed method is reliable with respect to robustness, specificity, reproducibility and superior system suitability parameters.