Development and Validation of RP-HPLC assay method for the Estimation of Dronedarone in bulk and Pharmaceutical Preparations
Journal Title: Scholars Academic Journal of Pharmacy - Year 2015, Vol 4, Issue 1
Abstract
A rapid and reproducible reverse phase high performance liquid chromatographic method has been developed for the estimation of Dronedarone in its pure form as well as in pharmaceutical dosage forms. Chromatography was carried out on an ODS C18 column (250 x4.6 mm x 5µm length), using a composition of water (0.2% Tri Ethyl Amine):Methanol (20:80v/v) pH adjusted to 3 with Ortho Phosphoric acid as the mobile phase at a Flow Rate of 1 mL/min and the detection was done at 283 nm. The retention time of the drug was 4.707 min. The method produced linear responses in the concentration range of 20-120µg/mL of Dronedarone. The method was found to be reproducible for analysis of the drug in Tablet preparations. Keywords: Dronedarone, RP-HPLC, tablets dosage forms, validation.
Authors and Affiliations
Sk Mastanamma, S. Krishna Chaitanya, P. Saidulu, K. Sravani
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