Development and Validation of RP HPLC Method for Estimation of Deferiprone and Its Related Impurity in Pharmaceutical Dosage Form
Keywords:Deferiprone, Maltol impurity, Method validation, RP HPLC
The 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 capsule dosage form. An extensive literature survey revealed no method for estimation of the above said. The chromatographic separation was achieved on Agilent Zorbax Bonus-RP (250 x 4.6 mm, 5 µ) with a mobile phase composed of Methanol: 0.1% O-Phosphoric acid (10:90, % v/v) in 1000 ml of Methanol: Water (50: 50, % v/v) using a diluent. gradient program at a flow rate of 1 mL/min with UV detectation at 280 nm. 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 was good. There exists a qualitative correlation between peak area and analyte concentration. The retention time for Deferiprone was found to be 2.29 min and its impurity was 8.65 min. Relative standard deviation values for Deferiprone is 0.45 and its process-related impurity is 0.17. All the results reveal that the proposed method was found to be 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 maltol impurity in bulk and pharmaceutical dosage forms.
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