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Analytical method development and validation for the determination of lafutidine using reverse phase HPLC method in bulk and tablet dosage form | Abstract
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Abstract

Analytical method development and validation for the determination of lafutidine using reverse phase HPLC method in bulk and tablet dosage form

Author(s): R. Vani1, B. Vijaya Kumar and G. Krishna Mohan

A new simple, accurate, precise and reproducible RP-HPLC method has been developed for the estimation of Lafutidine in bulk and pharmaceutical dosage form using C18 column (zodiac, 250 x 4.6 mm, 5 μm) in isocratic mode. The mobile phase consisted of A mixture of 30 volumes of 0.1MPhosphate buffer (KH2PO4) pH 4.0 and 70 volumes of Methanol is used v/v. The detection was carried out at 299 nm. The method was linear over the concentration range 60-140 μg/ml. The recovery of Lafutidine was found to be 100.29% . The validation of method was carried out utilizing ICH-guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing Lafutidine in tablet dosage form.