SIMULTANEOUS DETERMINATION AND VALIDATION OF CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLPROPANOLAMINE HYDROCHLORIDE AND CAFFEINE IN TABLET DOSAGE FORM BY USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC)

摘要

Objective: An accurate, simple, reproducible and sensitive reverse phase liquid chromatographic method for the simultaneous determination of Chlorpheniramine Maleate, Acetaminophen, Phenylpropanolamine Hydrochloride and Caffeine in tablet formulation. Method: Separation was achieved on Inertsil C18 (250mmx4.6mm, 5μn) analytical column. A mixture of acetonitrile: water: methanol (15:75:10 v/v/v) with buffer solution (pH=2.8) containing triethylamine (0.3 ml) and Hexansulfonic acid sodium salt as ion pair was used as mobile phase. Isocratic elution with program flow rate from 1 ml/min (in 0~5 min) to 1.7 ml/min (after 5 min) till 8 min was used and the detection was at 220 nm wavelength. Results: The retention time of Chlorpheniramine Maleate, Acetaminophen, Phenylpropanolamine Hydrochloride and Caffeine were found to be 3.423, 5.627, 6.052 and 7.690 min, respectively. The validation of the proposed method was carried out for linearity, accuracy, recovery, and precision and limit of detection and limit of quantification. The linear rang of determination of Chlorpheniramine Maleate, Acetaminophen, Phenylpropanolamine Hydrochloride and Caffeine were 1-50 μg/ml, 1-500 μg/ml, 1-200 μg/ml and 1-150 μg/ml, receptively. The percentage recovery of Chlorpheniramine Maleate, Acetaminophen, Phenylpropanolamine Hydrochloride and Caffeine were 101.650-101.640%, 100.305-99.484%, 100.840-100.751% and 98.075-100.461%, respectively. The detection limit and quantification limit for Chlorpheniramine Maleate, Acetaminophen, Phenylpropanolamine Hydrochloride and Caffeine were found to be 0.567 and 1.720 μg/ml, 0.467 and 1.415 μg/ml, 0.512 and 1.552 μg/ml and 0.7514 and 2.277 μg/ml, respectively. Conclusion: The developed method is suitable for routine quality control analysis of titled drugs in combination of tablet formulation