A Validated Stability-Indicating HPLC Assay Method for Cetrizine HCl in Bulk Drug

An isocratic reversed phase stability-indicating high-performance liquid chromatographic (HPLC) assay method was developed and validated for quantitative determination of Cetrizine hydrochloride in bulk drugs. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using an Thermo Hypersil C18 (250 x 4.6)mm,5μ column and the mobile phase containing 900 ml water and 200 ml 0.01M H2SO4 water filter and mixed. Prepare a homogenous mixture of buffer, and acetonitrile (80:20, v/v/v). The detection was carried out at wavelength 230 nm. The developed method was validated with respect to linearity, accuracy (recovery), precision, system suitability, selectivity, robustness prove the stability indicating ability of the method.