The Development and Validation of Stability Indicating HPLC Method for Estimation of Darunavir
To develop a new simple, precise and accurate HPLC method for estimation of Darunavir in tablet formulation. An isocratic, HPLC method was developed using C-18, 50 x 3 mm, 3.5 µm (X-Terra MS, Waters) column 0.1 % Acetic acid in water: ACN (63:37 v/v) as mobile phase at flow rate of 1.0 ml/min at detection wavelength of 267 nm. The retention time (RT) of drug was 3.123± 0.034 min . The method was validated with respect to linearity, precision, assay, accuracy and robustness. The data of linear regression analysis indicated a good linear relationship over the range of 5-30 μg/ml concentrations with a correlation coefficient(R 2) of 0.9995.The developed method was found to be simple, sensitive, selective, accurate, and precise for analysis of Darunavir and can be adopted for routine analysis of drug in bulk and pharmaceutical dosage form.
Keywords: High performance liquid chromatography (HPLC), Darunavir, method development, Validation.
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