Development and Validation of RP HPLC Method for Estimation of Deferiprone and its Related Impurityin Pharmaceutical Dosage Form

Abstract

Aim of this study is to develop a new, precise, sensitive, simple, efficient, selective, and accurate high-performance liquid chromatographic method for the separation and determination of Deferiprone and its impurity in the capsule dosage form. A wide-range of literature survey disclosed no method for estimation said as the above. The chromatographic separation was achieved on Agilent Zorbax Bonus-RP (250 x 4.6mm, 5µ) with a mobile phase of Methanol: 0.1% O-Phosphoric acid (10:90, % v/v) combination in 1000ml of Methanol: Water (50: 50, % v/v) using a diluent. The flow rate of 1mL/min and UV detection at 280nm use as wavelength. The developed method was validated as reported by ICH guidelines. The linearity of the calibration curve for deferiprone and its process-related impurity in the concentration range of 4.0-6.0μg/ml. There exists a good correlation between peak area and analyte concentration. The retention time for deferiprone was discovered to be 2.29 min and its impurity was 8.65min. Deferiprone's relative standard deviation value is 0.45 and its process-related impurity is 0.17. All the results tell that the proposed method was highly sensitive, simple, precise, accurate, and fast. A large number of samples can be analyzed in a shorter time due to shorter retention times, so it can be successfully applied for routine analysis of Deferiprone and related impurity (maltol) in pharmaceutical dosage forms.