SIMULTANEOUS DETERMINATION OF CHLORPHENIRAMINE MALEATE, GUAIPHENES1N, TERBUTALINE SULPHATE AND AMBRQXOL HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM BY UPLC

摘要

A reverse phase UPLC method has been developed and validated for the simultaneous estimation of terbutaline sulphate, guaiphenesin, chlorpheniramine maleate and ambroxol hydrochloride from its pharmaceutical oral liquid dosage form. The separation was obtained using a mobile phase consisting of 10 mM phosphate buffer adjusting pH to 2.5 with orthophosphoric acid and methanol by gradient elution, using Acquity BEH Shield RP18 (150 x 2.1 mm, 1.7mc) column maintained at 50deg. The flow rate was 0.30 mL min~(-1) and UV detection at 220nm for terbutaline sulfate, ambroxol hydrochloride, chlorpheniramine maleate & 273 nm for guaiphenesin was employed. The elution order was terbutaline (about 3.0 min), guaiphenesin (about 6.5 min), chlorpheniramine (about 6.8 min) and ambroxol (about 8.2 min). The linear dynamic range was 6.3 to 18.8 meg mL1 for terbutaline sulphate, 250 to 750 meg mL~(-1) for guaiphenesin, 10 to 30 mcg mL~(-1) for chlorpheniramine maleate and 75 to 225 meg mL~(-1) for ambroxol hydrochloride. The method validation results are within the acceptance criteria for precision, linearity, specificity, stability of solution and robustness.