Validated LC Method for the Estimation of Voriconazole in Bulk and Formulation

经验证的液相色谱法测定原料药和制剂中伏立康唑的含量

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Abstract

Reversed phase high performance liquid chromatographic method was developed and validated for the estimation of voriconazole in bulk and formulation using prominence diode array detector. Selected mobile phase was a combination of water:acetonitrile (35:65 % v/v) and wavelength selected was 256 nm. Retention time of voriconazole was 3.95 min. Linearity of the method was found to be 0.1 to 2 mug/ml, with the regression coefficient of 0.999. This method was validated according to ICH guidelines. Quantification was done by calculating area of the peak and the detection limit and quantitation limit ware 0.026 mug/ml and 0.1 mug/ml, respectively. There was no significant difference in the intra day and inter day analysis of voriconazole determined for three different concentrations using this method. Present method can be applied for the determination of voriconazole in quality control of formulation without interference of the excipients.

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