Development and validation of RP-HPLC method for the simultaneous estimation of paracetamol, aceclofenac and rabeprazole sodium in bulk and its pharmaceutical dosage form

G. Saravanan, Mohammad Yunoos

Abstract

A novel, simple, precise, accurate, sensitive, rapid, economic and isocratic RP-HPLC method has been developed for the simultaneous estimation of paracetamol, aceclofenac and rabeprazole sodium in bulk and its pharmaceutical dosage form. The chromatographic separation was achieved on waters 2675 HPLC separation module equipped with Agilent CN column (250 X 4.6 mm, 5 μ particle size) and UV detector using ammonium acetate buffer (pH 7.5) and acetonitrile in the ratio of 70:30 % v/v as mobile phase at a flow rate of 1.0 ml/min. The detection was carried out at 213 nm. The retention time of paracetamol, aceclofenac and rabeprazole sodium was found to be 3.678, 5.556 and 9.572 min respectively. Linearity was observed in the concentration range of 16-488 μg/ml for paracetamol, 5- 150 μg/ml for aceclofenac and 0.5-16.8 μg/ml for rabeprazole sodium. % Recoveries for paracetamol, aceclofenac and rabeprazole sodium were found to be 100.45 %, 100.47 % and 100.47 % respectively. The % RSD below 2.0 shows the high precision of the proposed method. The method was validated for precision, linearity, accuracy, specificity and robustness in accordance with ICH guidelines and can be applied for routine analysis of paracetamol, aceclofenac, and rabeprazole in bulk and its pharmaceutical dosage form.

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