Abstract

A validated stability-indicating HPLC assay method for buclizine hydrochloride in bulk drug and dosage form

Author(s): Vitthal D.Dhakane, Milind B.Ubale

An isocratic reversed phase stability-indicating high-performance liquid chromatographic(HPLC) assay method was developed and validated for quantitative determination of buclizine hydrochloride in bulk drugs and the degradation products generated from forced decomposition. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using an GraceAlpha C18 (250 x 4.6)mm,5u column and the mobile phase containing the ofmixture of triethylamine-phosphoric acid buffer (pH-3 by orthophosphoric acid, acetonitrile (20:80,v/v). The detection was carried out at wavelength 230 nm. The chromatographic resolution between its degraded products was found to be greeter than three. The buclizine hydrochloride was subjected to stress conditions of hydrolysis (acid, base), oxidation (30%H2O2) and thermal degradation.The degradation was observed for buclizine hydrochloride in acid,base and 30 % H2O2 and negligible degradation observed in thermal hydrolysis.. The mass balance was close to 100 in all the stress conditions. The degraded products were well resolved from main peak. The developed method was validated with respect to linearity, accuracy (recovery), precision, system suitability, selectivity, robustness and forced degradation studies prove the stability indicating ability of the method.