The present work aims at development and validation of reverse phase liquid chromatographic method for determination of ledipasvir and related impurity in bulk and pharmaceutical dosage form. The chromatographic separation was achieved with Zorbax eclipse XDB C18 column (250 mm x 4.6 mm, 5 micro) using buffer (0.03 M potassium dihydrogen phosphate in 1000 ml water) and acetonitrile (40:60). The flow rate of 1.0 ml/min with detection of 264 nm was used in the analysis. The calibration curve of ledipasvir was linear in the range of 120 microgram â?? 360 microgram. The method was validated with respect to linearity, precision, accuracy, specificity, robustness in accordance with ICH guidelines. The method was found to be accurate, specific, precise, simple and robust to analyze ledipasvir and related impurity in bulk and pharmaceutical dosage form.
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