A NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF FLUVOXAMINE IN BULK AND TABLET DOSAGE FORM
Umme Kulsum* and Naveen Kumar G. S.
A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Fluvoxamine in pharmaceutical dosage form. Chromatographic separation of Fluvoxamine was achieved on Prominence LC-20A Quaternary Gradient HPLC system, by using Shimpack C-18 (5μm, 4.6 x 250mm) column and the mobile phase containing Acetonitrile and Phosphate Buffer with pH of 4.5 in a 54:45 v/v ratio. The flow rate was 1.0ml/min; detection was carried out by absorption at 254 nm using a UV detector at ambient temperature. LOD and LOQ were found to be 6.39μg/ml and 19.36μg/ml respectively and retention time was found to be 3.66mins. The % Recovery was found to be 99.42-100.71%. The number of theoretical plates and tailing factor for Fluvoxamine were not less than 2000 and not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate and robust method for quantitative analysis of Fluvoxamine.
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