title: 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 Cmax, AUC(0-t) and AUC(0-infinity) values for the test and reference products, using logarithmic transformed data. The 90% confidence intervals for the ratio of Cmax (83.7-118.4%), AUC(0-t) (91.1-113.4%) and AUC(0-infinity) (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 Cmax), 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.
authors.affiliation: Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital of Zhejiang University, Hangzhou PR China.
authors.forename: Jian
authors.initials: J
authors.lastname: Liu
authors.forename: Jianzhong
authors.initials: J
authors.lastname: Shen-Tu
authors.forename: Lihua
authors.initials: L
authors.lastname: Wu
authors.forename: Jing
authors.initials: J
authors.lastname: Dou
authors.forename: Qiyang
authors.initials: Q
authors.lastname: Xu
authors.forename: Huili
authors.initials: H
authors.lastname: Zhou
authors.forename: Guolan
authors.initials: G
authors.lastname: Wu
authors.forename: Xingjiang
authors.initials: X
authors.lastname: Hu
mesh_terms: D000409:Alanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000097:blood* / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D003511:Cyclohexanols / Q000032:analysis; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D011786:Quality Control; D015363:Quinolones / Q000009:adverse effects / Q000097:blood* / Q000493:pharmacokinetics*; D015203:Reproducibility of Results; D013607:Tablets; D053719:Tandem Mass Spectrometry; D013810:Therapeutic Equivalency; D000069470:Venlafaxine Hydrochloride; D055815:Young Adult
chemical_list: D000897:Anti-Ulcer Agents; D003511:Cyclohexanols; D015363:Quinolones; D013607:Tablets; D000069470:Venlafaxine Hydrochloride; C052785:rebamipide; D000409:Alanine