SIMPLE DETERMINATION OF ERDOSTEINE IN HUMAN PLASMA USING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Abstract

A simple and rapid high-performance liquid chromatography (HPLC) method with UV detection (220 nm) was developed for the determination of erdosteine in human plasma. The plasma was prepared by deproteination based on treatment with 6.25% trichloroacetic acid (TCA). After the mixture was centrifuged, the supernatant was separated on CAPCELL PACK C₁₈(4.6 × 250 mm) column. The mobile phase consisted of acetonitrile in phosphate-heptane sulfonate buffer at the volume ration of 5:95 (pH 2.0). Citiolone was used as an internal standard. The calibration curve was linear in concentrations of 0.5–8 μg/mL with correlation coefficient of 0.999. The limit of quantitation (LOQ) was 0.5 μg/mL. This method was sensitive with reproducibility and specificity and successfully applied to the bioequivalence study of erdosteine (900 mg) in healthy subjects.

Keywords:

• bioequivalence
• erdosteine
• HPLC
• UV

ACKNOWLEDGMENTS

This work was financially supported by the Ministry of Education and Human Resources Development (MOE), the Ministry of Commerce, Industry, and Energy (MOCIE), and the Ministry of Labor (MOLAB) through the fostering project of the Lab of Excellency. S. T. Kim was also supported by a grant from KICOS through the Korea Ministry of Science & Technology (K20704000007–09A0500–00710).

Notes

^a AUC: area under the plasma concentration versus time curve.

^b C_max: peak plasma concentration.

^c T_max: time to reach C_max.