Stability indicating rapid RP-HPLC method for the determination of Drotaverine hydrochloride, Domperidone and paracetamol in pharmaceutical dosage forms

By Kabeer A. Shaikh and Sachin D. Patil

ABSTRACT


A simple and precise high performance liquid chromatographic method has been developed and validated for the simultaneous determination of drotaverine hydrochloride, domperidone and paracetamol in a binary tablet formulation containing drotaverine hydrochloride-paracetamol and/or domperidone-paracetamol. Chromatography was carried out at 25°C on a 4.6mm×150mm, 5µm Symmetry shield RP 18 column with the isocratic mobile phase of 0.02M aqueous potassium dihydrogen phosphate buffer (pH 7.5) and acetonitrile (40:60, v/v) at a flow rate of 0.5 ml/min. Drotaverine hydrochloride, domperidone and paracetamol were separated in less than 10 min with good resolution and minimal tailing, without interference of excipients. The method was validated according to ICH guidelines and the acceptance criteria for accuracy, precision, linearity, specificity and system suitability were met in all cases. The method was linear in the range of 192–448µg/ml for drotaverine hydrochloride, 24–56µg/ml for domperidone and 12–28µg/ml for paracetamol.

Key words: Drotaverine hydrochloride, Domperidone, Paracetamol, liquid chromatography, formulation.

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