alexa Abstract | Development and Validation of RP-HPLC Method for Quantitation of Itraconazole in Tablets Dosage Form

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A simple, selective, accurate and precise high performance liquid chromatographic (HPLC) method for estimation of Itraconazole in tablets was developed and validated. The determination was carried out using ODS Hypersil C18 column (250 X 4.6) mm 5μ, with a mobile phase consisting of a mixture of Acetonitrile and 0.2% Triethylamine in isocratic elution. The flow rate was kept at 1.0ml /min and the detection was carried out by UV Detector at 260 nm. The retention time of Itraconazole was about 4 minutes. The method was validated for specificity, limit of detection, limit of quantification, linearity, accuracy, precision and robustness following ICH guidelines. This method permits determination of Itraconazole in tablets with detection limit 0.3 ppm and quantification limit 1.0 ppm. The linear regression analysis data for the calibration curve in the range of 1.0 ppm to 100 ppm showed good linear relationship with coefficient of correlation value, r2 = 0.9972. All the parameters of validation were under the limit as specifiy by the ICH guidelines. Hence, this method is suitable for determination of Itraconazole in pharmaceutical dosage form. The method was found to be specific, linear, precise, accurate, robust and because of these parameter, this method was found effective for routine analysis.

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Author(s): Manish K Gupta, Sarika Rajput

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