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Open Access Development of a simple LC-MS/MS method for determination of rebamipide in human plasma and its application to a bioequivalence study

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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

DOI: https://doi.org/10.1691/ph.2012.2018

Publication date: 2012-11-01

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  • Pharmazie is a leading journal in the field of pharmaceutical sciences. As a peer-reviewed scientific journal, Pharmazie is regularly indexed in the relevant databases like Web of science, Journal Citation Reports and many others. The journal is open for submissions from the whole spectrum of pharnaceutical sciences including Pharmaceutical Chemistry, Experimental and Clinical Pharmacology, Drug Analysis, Pharmaceutics, Pharmaceutical Biology, Clinical Pharmacy etc.
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