Method Development and Validation by RP-HPLC for Simultaneous Estimation of Paracetamol, Caffeine, Phenylephrine and Chlorpheniramine in Tablet Dosage Form

摘要

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 tablet dosage form. The HPLC method includes use of Cosmosil C-18 (250×4.6mm, 5.0μm) column, a mobile phase consisting of buffer and Methanol at 1.00 ml/minute flow rate and gradient determination with UV detector at 220 nm. Retention time was found to be 4.33, 10.36, 13.85 and 17.35 minutes for Phenylephrine HCL, Paracetamol, Caffeine and Chlorpheniramine Maleate 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, specificity, limit of quantitation, limit of detection 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 tablet dosage form.