Abstract
Purpose: This study aims to develop and validate a RP-HPLC method for simultaneous estimation of deferiprone and its synthesized impurity. Method: 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℃. Result: 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. Conclusion: 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.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
