SIMULTANEOUS QUANTITATION AND VALIDATION OF PHENYLEPHRINE HYDRO-CHLORIDE, AMBROXOL HYDROCHLORIDE AND LEVOCITRIZINE HYDROCHLORIDE IN SYRUP FORMULATION BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

摘要

A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of Phenylephrine hydrochloride, Ambroxol hydrochloride and Levocetirizine hydrochloride in syrup formulation. This method is based on HPLC separation of the three drugs on Octadecyl Silane C18 column (250 mm × 4.6 mm, 5.0μ), with isocratic conditions and mobile phase containing 0.01M Sodium dihydrogen phosphate monohydrate buffer [pH 3.0, adjusted with Ortho Phosphoric Acid and 1.1 gm of Octane sulfonic acid sodium salt]: Acetonitrile: Methanol (60:30:10) at a flow rate of 1 ml/min, using UV detection at 230 nm. The retention time of Phenylephrine hydrochloride, Ambroxol hydrochloride and Levocetirizine hydrochloride in syrup formulation were found to be around 3.47 min, 11.8 min and 32.6 min respectively. The method was validated for linearity, accuracy, precision, ruggedness, robustness and solution stability as per ICH guidelines. The linearity of Phenylephrine hydrochloride, Ambroxol hydrochloride, Levocetirizine hydrochloride solutions ranged from 0.104 mg/ml to 0.303 mg/ml; 0.6 mg/ml to 1.804 mg/ml and 0.051 mg/ml to 0.150 mg/ml, respectively, equivalent to 50% to 150% of the working concentration. Statistical analysis showed that the proposed method is repeatable and selective for the estimation of Phenylephrine hydrochloride, Ambroxol hydrochloride and Levocitrizine hydrochloride in syrup formulation.