Development and Validation of RP-HPLC Method for Simultaneous Estimation of Three-Component in Tablet Dosage Formulation

An accurate, simple, reproducible and sensitive method for the determination of paracetamol, caffeine and chlorpheniramine maleate in tablet dosage form is developed and validated. The separation is achieved using HiQsilC18HS reverse-phase column (250 X 4.6 mm I.D., particle size 5 μm) using a mixture of acetonitrile and water in the proportion 55:300 with final pH of 2.4 adjusted with o-phosphoric acid as a mobile phase. The flow rate is 1.0 mL/ min and effluents were monitored at 265 nm. Total run time is less than 12 min. and retention time of paracetamol, caffeine and chlorpheniramine maleate are 6.742, 9.417, and 3.683 min respectively. Validation of method is done as per ICH guideline for accuracy, precision, linearity, specificity, and sensitivity. The linearity for paracetamol is found to be 100-650 μg/mL where as for caffeine and chlorpheniramine maleate is found in the range of 15-100 μg/mL. Result of validation study is found statistically significant because all the statistical parameters were within the acceptance range (COV and S.D. <1.0 for both accuracy and precision). The limits of detection (LOD) values are 1.2014, 0.4587 and 0.8945 and limit of quantitation (LOQ) values are 0.5142, 0.4512 and 0.7845 μg/mL for paracetamol, caffeine and chlorpheniramine maleate respectively. High percentage recovery and low COV value revealed the reliability of the method for quantitative study of three drugs in Fevril tablets as a quality-control tool for routine quantitative determination of paracetamol, caffeine and chlorpheniramine maleate.