VALIDATED RP-HPLC METHOD FOR FLUVASTATIN SODIUM IN BULK AND ITS DOSAGE FORM
Journal Title: Journal of Pharmaceutical Sciences and Research - Year 2009, Vol 1, Issue 3
Abstract
A Simple, selective and rapid reverse-phase high Performance Liquid Chromatography (RP-HPLC) method for the analysis of fluvastatin sodium in bulk and in tablet dosage form has been developed and validated. The method was carried out on a Hypersil® ODS C18 (150 x 4.6 mm, 5micron) column. The mobile phase consists of methanol: 20mM Phosphate buffer (pH 3.0 adjusted with Phosphoric acid): acetonitrile (5: 3: 2 v/v.) was delivered at a flow rate of 1.2 ml/min at ambient temperature and the retention time was about 7.65 minutes with symmetrical peaks. Studies was performed on an HPLC System equipped with uv/vis detector at 235nm.The method is specific to fluvastatin sodium and able to elute the peak from formulation excipients. The calibration curve was linear over the concentration range of 1 - 6 μg/ml (R2=0.9998). The proposed method was accurate (the accuracy results were 98.31- 99.70 for fluvastatin recoveries. precise (the intraday and interday precision of CVs were 0.2073- 0.8976 % for fluvastatin sodium recoveries) and linear within the desired range. the lower limits of detection for FVS was found to be 0.0194μg/ml and the quantitation limit was about 0.0588 μg/ml and therefore could be employed as more convenient and efficient for the analysis of fluvastatin sodium in bulk and its formulation. Keywords: Fluvastatin sodium; method validation; C18 column; RP- HPLC determination;
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SAMINATHAN
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