Simultaneous determination of four active pharmaceuticals in tablet dosage form by reversed-phase high performance liquid chromatography

摘要

Purpose: To develop a single, low-cost and rapid analytical method for the simultaneous determination of four active components - chlorpheniramine maleate, paracetamol, phenylephrine hydrochloride and caffeine – in a tablet dosage form. Method: This method was based on reverse-phase high performance liquid chromatography (RP-HPLC) and involved the use of a C-18 column (250 × 4.6 mm, 5.0 μm), a mobile phase consisting of buffer solution and methanol at a flow rate of 1.00 mL/min, and gradient determination with UV detection at 220 nm. Results: Retention time was 4.33, 10.36, 13.85, and 17.35 min for phenylephrine hydrochloride, paracetamol, caffeine, and chlorpheniramine maleate, respectively. Specificity data showed no interference from the excipients, and accuracy of the method was close to 100 %. The method was validated as per the guidelines of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and all the results met the acceptance criteria for accuracy, precision, linearity, specificity, limit of quantitation, limit of detection, and robustness. Conclusion: This method can successfully perform quantitative assessment of phenylephrine HCl, chlorpheniramine maleate, paracetamol, and caffeine in tablet combination dosage forms faster and more cost-effectively than conventional methods.