Abstract

SANCHEZ-HOYOS, Fredys et al. Validation of an analytical HPLC method for the quantification of warfarin sodium in tablets. Rev. colomb. cienc. quim. farm. [online]. 2016, vol.45, n.3, pp.470-483. ISSN 0034-7418.  https://doi.org/10.15446/rcciquifa.v45n3.62053.

The analytic methodology for the quantification of sodium warfarin tablets of 5 mg was standardized and validated by High Efficiency Liquid Chromatography coupled to Diode Array Detector (HPLC-DAD). A mixture of MeOH-AcOH-H2O (68:1:32) was used like mobil phase, a chromatographic column C8e Phenomenex^® of 150x4.6 mm and a particle size of 5 μm. The analytic results show that the method is precise, accurate and selective for this drug. The calibration curve was performed in the range of 80 to 120% at a nominal concentration of 0.1 mg/mL, demonstrating to be linear with a correlation coefficient at r²> 0.990; recovery rate was 98.1% ± 1.3 and the precision measured through repeatability and intermediate accuracy was adequate (% RSD <2). A percent of 92.3% ± 3.0 was found in dissolution test, thus, the methodology developed complies with the specifications established by USP 38/NF33.

Keywords : Validation of analytical methods; sodium warfarin; HPLC-DAD.

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