Stability indicating method development and validation of Deferiprone in pharmaceutical dosage form by RP-HPLC

Abstract

The objective of this present is to develop a simple, precise, accurate stability indicating method for the estimation of deferiprone in formulation by using RP-HPLC. The separation was achieved on Inertsil ODS C18, 250x 4.6mm, 5µm i.d. column using 60 volumes of Mixed Phosphate  buffer(KH₂PO₄+K₂HPO₄) pH 3.0 and 40 volumes of  methanol as mobile phase and at a flow rate of 1.0  mL/min. Detection was carried out using a PDA detector at 280nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The total chromatographic analysis time per sample was about 5 min with deferiprone eluting at retention time of about 4.980 min. The method was validated as per ICH guide lines. Stability studies reported absence of impurities at the peak retention time. The drug was stable to different conditions like acidic, alkali, thermal, oxidative and photolytic conditions. Validation studies demonstrated that the proposed HPLC method is simple, specific, rapid, reliable and reproducible. The standard curves were linear over the concentration range of 75-125µg/mL. The LOD and LOQ values for deferiprone were 3.91 and 11.8 µg/mL, respectively. The percentage recovery was found to be 97.3 to 98.0 and the %RSD for precision was found to be 0.5. The high recovery and low relative standard  deviation confirm  the  suitability  of  the  proposed  method for the determination  of  deferiprone in  bulk  and  capsule  dosage  forms