STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl AND CHLORPHENIRAMINE MALEATE IN THEIR COMBINED SYRUP DOSAGE FORM BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
The present work describes a validated reverse phase high performance liquid chromatographic method for simultaneous estimation of Dextromethorphan HBr, Phenylephrine HCl and Chlorpheniramine Maleate in syrup dosage form. The quantification was carried out using Phenomenex Luna 5µm C8(2)100Å;250×4.6mm (Part No.00G-4249-E0) column and mobile phase comprised of Buffer pH 3.2 and Acetonitrile with gradient elution mode. The flow rate was 1.0 ml/min and the eluent was monitored at 220 nm. The selected chromatographic conditions were found to effectively separate Dextromethorphan HBr, Phenylephrine HCl and Chlorpheniramine Maleate were about 11.1 min, 3.7 min and 10.3 min respectively. Linearity were found to be in the range of 80-120 μg/ml, 40-60 μg/ml and 16-24 μg/ml for Dextromethorphan HBr, Phenylephrine HCl and Chlorpheniramine Maleate respectively. The percentage recoveries of all the drugs were found to be 100.5-101.8%, 99.2-101.8% and 100.1-101.8% for Dextromethorphan HBr, Phenylephrine HCl and Chlorpheniramine Maleate. The proposed method was found to be fast, specific, accurate, precise, and reproducible and can be used for simultaneous estimation of these drugs in syrup formulation.
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