Development and Validation of RP-HPLC method for simultaneous estimation of Eperisone Hydrochloride and Diclofenac Sodium in Pharmaceutical Dosage Form
A simple, specific, precise and accurate Reverse-phase High Performance Liquid Chromatographic method has been developed for the simultaneous estimation of Eperisone Hydrochloride and Diclofenac Sodium in combined pharmaceutical dosage form. The chromatographic separation was carried out on Phenomenex C18 column (250 × 4.6mm) by isocratic elution using 30mM phosphate buffer pH 2.5: methanol (20:80 v/v), as mobile phase at a flow rate of 1ml/min. Detection and quantification of all the analytes was carried out at 268 nm by using photo diode array detector. The retention time of Eperisone and Diclofenac was found to be 2.803 and 6.793 min respectively. The calibration curves of Eperisone and Diclofenac were linear over the concentration range of 15 - 90 μg/ml and 10 - 60 μg/ml with correlation of 0.9992 and 0.9994 respectively. The % amount of Eperisone and Diclofenac in capsule dosage form was found to be 99.64% and 99.27% respectively. The developed method was validated as per ICH guidelines. The limit of detection and limit of quantification were 0.45 and 1.36 μg/ml for Eperisone and 0.14 and 0.43 μg/ml for Diclofenac respectively. As there was no interference of excipients, the proposed method can be applied for the simultaneous estimation of the two drugs in routine quality control analysis of formulation.
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