Development and Validation of a Stability Indicating RP-HPLC Method for the Estimation of Deferiprone in its Capsule Dosage Form

Abstract

A simple, precise, new stability indicating RP-HPLC method was developed and validated for the determination of deferiprone in its solid pharmaceutical dosage form. The reverse phase high performance liquid chromatography (RP-HPLC) was used for the quantitative determination of deferiprone using UV/VIS detector. The chromatographic separation was carried out on Zorbax SB C18 column (4.6*250 mm,5 um) with a mobile phase of methanol-buffer (25mM Potassium dihydrogen phosphate and 1ml TEA in 1000 ml at (PH 3.5)) in the (40:60% v/v) ratio. The detection wavelength was found to be 280nm with a flow rate 0.6 ml/min and temperature of 40°C.The retention time of deferiprone was found to be 4.7 min. The developed method was validated in accordance with ICH guidelines (ICH Q2 R1). The calibration curve was found to be linear over the concentration range of 10-150µg/ml and shows correlation coefficient (r2) of 0.999. Deferiprone was found to have LOD and LOQ values of 3.3ug/ml and 10.1ug/ml, respectively. The percent recovery of deferiprone was found to be within limit.The method was found to be robust even by change in flow rate, temperature, and wavelength. The developed method can be successfully employed in a routine analysis of deferiprone in pharmaceutical dosage form. Force degradation studies were also carried out by exposing the deferiprone samples in a various stress condition such as acidic, alkaline, hydrolytic, oxidative, thermal, photolytic degradation to establish the specificity of method.