Validation of a LC method for the analysis of zafirlukast in a pharmaceutical formulation

A reversed-phase high-performance liquid chromatographic (HPLC) method was developed and validated for estimation of zafirlukast in a pharmaceutical f ormulation. Assay samples were extracted utilizing acetonitrile. Drug and i nternal standard were chromatographed on reversed-phase C-18 columns, using mixtures of acetonitrile/water and the eluents were monitored at different wavelengths. The method was validated statistically for its linearity, acc uracy, robustness and precision. Experimental design was used during valida tion to evaluate method robustness and for the determination of intermediat e precision. Factors examined for statistical approaches include laboratory , day, analyst, instrument, different percentage of organic modifier, tempe rature, wavelength and flow-rate. Due to its simplicity and accuracy, the m ethod may be used for routine quality control analysis. (C) 2000 Elsevier S cience B.V. All rights reserved.