1Ashokrao Mane College of Pharmacy, Peth-Vadgaon
2New College of Pharmacy, Kolhapur
*Corresponding Author E-mail: shubhangi.sutar28@gmail.com
Online Published on 13 October, 2023.
This study aims to develop and validate a RP-HPLC method for simultaneous estimation of deferiprone and its synthesized impurity.
Structure of impurity was confirmed by spectral analysis while their purity was confirmed by HPLC analysis. The chromatographic separation was achieved on Agilent Zorbax Bonus-RP (250 x 4.6mm, 5μ) using mobile phase of 20 ACN-80 0.1% TFA. Detection was carried out at 280 nm using PDA detector with flow rate of 1 ml/min and temperature of 30°.
The method was validated as per ICH guidelines. The percent recovery was found to be within limit and %RSD for deferiprone and the impurity was found to be 0.09 and 0.48. The standard curve was linear over the concentration range of 60-140μg/ml and shows correlation coefficient (r2) of 1. The LOD and LOQ values for deferiprone were found to be 0.21μg/ml and 0.62μg/ml respectively. The method was found to be robust even by change in flow rate of ±0.2ml/min.
Validation studies demonstrated that the proposed HPLC method is specific, reliable, rapid and reproducible. The developed method can be successfully employed for routine analysis for deferiprone in pharmaceutical dosage form.
Simultaneous Estimation, RP-HPLC, Deferiprone, Impurity, Validation
