Der Pharmacia Lettre
Abstract
Author(s): Kabeer A. Shaikh, Sachin D. Patil
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, 5?Ž?¼m 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?¢?????448?Ž?¼g/ml for drotaverine hydrochloride, 24?¢?????56?Ž?¼g/ml for
domperidone and 12?¢?????28?Ž?¼g/ml for paracetamol.
