SIMULTANEOUS QUANTITATION AND VALIDATION OF CHLORPHENIRAMINE MALEATE, PHENYLPROPANOLAMINE HYDROCHLORIDE AND PARACETAMOL BY RP-HPLC IN BULK DRUG AND FORMULATION

A HPLC method has been described for simultaneous determination of Chlorpheniramine Maleate, Phenylpropanolamine Hydrochloride and Paracetamol in formulation. This method is based on HPLC separation of the three drugs on the Thermo Hypersil Gold C18 column(250mm ×4.6mm, 5.0µ), with isocratic conditions and mobile phase containing methanol: 0.01M disodium hydrogen phosphate dihydrate buffer pH 7 adjusted with Ortho Phosphoric Acid (OPA) (60: 40) at a flow rate of 1mL/min using UV detection at 217 nm. This method has been applied to formulation without interference of excipients of formulation. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 0.5-3µg/mL for Chlorpheniramine Maleate, 7-12µg/mL for Phenylpropanolamine hydrochloride, and 0.4-1.4µg/mL for Paracetamol, respectively. The mean values of the correlation coefficient, slope and intercept were 0.999 ± 1.72, 28455 ± 1.01, 26185 ± 1.28 for Chlorpheniramine Maleate, 0.999 ± 0.34, 23604 ± 1.16, 73758 ± 1.49 for Phenylpropanolamine hydrochloride and 0.999 ± 0.80, 51233 ± 1.89, 5560 ± 1.62 for Paracetamol respectively. The method was validated for precision, robustness and recovery. The limit of detection (LOD) and limit of quantitation (LOQ) was 0.5μg/mL and 1μg/mLfor Chlorpheniramine Maleate, 5μg/mL and 7μg/mL for Phenylpropanolamine hydrochloride and 0.2µg/mL and 0.4µg/mL for Paracetamol, respectively. Statistical analysis showed that the method is repeatable and selective for the estimation of, Chlorpheniramine Maleate, Phenylpropanolamine hydrochloride and Paracetamol.