Development of a simple LC-MS/MS method for determination of rebamipide in human plasma and its application to a bioequivalence study
Abstract:The purpose of this study was to design a simple and rapid liquid chromatography-tandem mass spectrometric (LC-MS/MS) method for a rebamipide bioequivalence study in healthy Chinese male volunteers. In this method, sample pretreatment involved simple protein precipitation with venlafaxine as the internal standard. Analysis was achieved on a ZORBAX SB-C18 column with a concentration range of 6∼1200 ng/mL. Rebamipide tablets from Yuanlijian (test, Hangzhou, China) and from Otsuka (reference, Hangzhou, China) were evaluated following a single 300 mg oral dose to 20 healthy volunteers. Bioequivalence was determined by calculating 90 % confidence intervals (90 % CI) for the ratio of C max, AUC 0–t and AUC 0–∞ values for the test and reference products, using logarithmic transformed data. The 90 % confidence intervals for the ratio of C max (83.7∼118.4 %), AUC 0–t (91.1∼113.4 %) and AUC 0–∞ (90.6∼113.2 %) values for the test and reference products were within the interval (80.0∼125.0 % for AUC, and 70∼143 % for C max), proposed by State of Food and Drug Administration [SFDA, 2005. China]. It was concluded that the two rebamipide tablets were bioequivalent in their rate and extent of absorption and the method met the principle of quick and easy clinical analysis.
Document Type: Research Article
Publication date: November 1, 2012
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