Analytical method development and validation of Phenylephrine Hydrochloride,Chlorpheniramine Maleate, Paracetamol and Caffeine in bulk Drug and Tablet dosageform by RP-HPLC

Article history A new and simple reverse phase high performance liquid chromatographic method has been developed and validated for determination of Phenylephrine hydrochloride, Chlorpheniramine maleate, Paracetamol and Caffeine in pure drug and tablet dosage form. The HPLC method includes use of GraceE C-18 (250×4.6mm, 5.0μm) column, a mobile phase consisting of Acetonitrile: phosphate buffer pH 3.0 adjusted with ortho-phosphoric acid (10%) in the ratio of 10:90 (v/v) at 0.8 ml/min flow rate and isocratic determination with UV detector at 230 nm. Retention time was found to be 3.63, 4.53, 6.45 and 10.58 min for Phenylephrine HCl, Chlorpheniramine maleate, Paracetamol and Caffeine respectively. The method was validated as per ICH guidelines and applied to tablet dosage form without any interference from excipients. The validation characteristics included accuracy, precision, linearity, range, specificity, limit of quantitation and robustness. Validation acceptance criteria were met in all cases. This method can be used successfully for the quality assessment of Phenylephrine HCl, Chlorpheniramine maleate, Paracetamol and Caffeine in bulk and tablet dosage form.