Determination and Assay Validation of Bioactive Sesquiterpene Lactone Isolated from Xanthium cavanillesii Using Capillary Electrophoresis

FAVIER, L. S., ACOSTA, G., GOMEZ, M. R., MARÍA, A. O. AND TONN, C. E.

PHARMAZIE

Govi Verlag

Lugar: Eschborn; Año: 2006 vol. 61 p. 981 - 984

0031-7144

This study describes the development and validation of a method for quantification of the antiulcer experimental drug xanthatin in tablets by Capillary Electrophoresis (CE). Solid oral dosage forms based on xanthatin were designed and assayed on rats. A CE methodology was developed, the parameters evaluated were: background electrolyte composition, concentration and pH, applied voltage and sample preparation. The method was validated in terms of range of linearity, limits of detection (LOD) and quantification (LOQ), accuracy, precision and selectivity and then applied to the pharmaceutical dosage forms. Xanthatin determination was carried out in less than 3 minutes with a 20 mM sodium tetraborate buffer, pH 9.20. Drug concentration per tablet found was 2.97 mg ±0.2. Calibration plots were linear over at least three orders of magnitude of analyte concentrations, LOD and LOQ were 7.6 and 26 mg mL-1 respectively. For accuracy evaluation a recovery test was performed, the values were better than 98.6 %. Respect to the precision, the results obtained were better than 1.02 RSD % (repeatability) and 1.54 % (intermediate precision). After the manufacturing process the resulting tablets were biologically actives. The developed methodology is useful, simple and rapid for xanthatin determination in tablets.