Analytical Method Development and Validation for Assay of Rufinamide Drug
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Date
2013-11
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Publisher
Chitkara University Publications
Abstract
A simple, rapid, sensitive, cost effective, and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the stability testing of rufinamide. The proposed RP-HPLC method was developed on phenome-nex LunaR C-18 5μm,250 mm × 4.6 mm id. Column (at ambient temperature) and a mobile phase consisting of phosphate buffer: acetonitrile (60:40) was delivered at a flow rate of 1.0ml/ min. The analyte was detected by using a UV detector at the wavelength of 293 nm. The method was found to be linear over the concentration range of 50- 150 μgml-1 (r2=0.999). 30. The retention time of rufinamide was 4.717 min.
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Keywords
RP-HPLC, Rufinamide, API, Method Validation