A rapid and accurate assay for the determination of roxatidine, a selective H2-receptor blocker, in human plasma was developed. Analysis was performed by high-performance liquid chromatography (HPLC) with ultraviolet (UV) detector. Roxatidine acetate, a prodrug of roxatidine, is metabolized rapidly to roxatidine following oral administration. Roxatidine and the internal standard (ranitidine) were extracted from plasma by solid-phase extraction. The mobile phase of HPLC was consisted of 20 mM KH2PO4 (pH 7.0) and acetonitrile (5:1, v/v). The calibration curve for roxatidine was linear over the range of 5 to 1000 ng/mL. The precision and accuracy of within- and between-run were within 10% for roxatidine. The recovery of roxatidine was over 87% for both low and high concentrations (15 and 500 ng/mL) and the lower limit of quantitation (LLOQ) was 5 ng/mL. The method was successfully applied to a pilot pharmacokinetic study of roxatidine in healthy subjects.
Kuo, C.-W.; Liaw, W.-J.; Huang, P.-W.; and Pao, L.-H.
"A rapid and sensitive HPLC method for determination of roxatidine in human plasma,"
Journal of Food and Drug Analysis: Vol. 16
, Article 3.
Available at: https://doi.org/10.38212/2224-6614.2350