Application of HPLC method using normal phase column in a comparative pharmacokinetic study of two sulpiride tablet formulations

Ming Chuan Huang, Hsiu O. Ho, Geng Cheng Yeh, Wen Ting Ke, Li Chin Lin, T. M Bruce Hsu, Ming Thau Sheu

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

An HPLC method using normal phase column eluted with an aqueous solvent and detected by fluorescence was applied to analyze sulpiride concentrations in plasma samples obtained from a comparative pharmacokinetic study. This comparative study was conducted to determine the bioequivalence of two tablet products (Dogmatyl and Sulpin) containing sulpiride on 12 normal healthy Chinese male volunteers in a single-dose, two-period, two-sequence, two-treatment crossover design. The pharmacokinetic parameters, AUC 0-last, AUC 0-inf, and C max, were calculated from plasma data and compared using the SAS General Linear Model computer program. A two one-sided t distribution test was also performed, as well as the 90% confidence interval method, to determine the mean difference of these three pharmacokinetic parameters. The results suggest that these two sulpiride tablet products are bioequivalent when orally administered in a 400 mg single dose of two tablets.

Original languageEnglish
Pages (from-to)1-6
Number of pages6
JournalJournal of Food and Drug Analysis
Volume10
Issue number1
Publication statusPublished - 2002

Keywords

  • Bioequivalence
  • HPLC
  • Normal phase column
  • Sulpiride

ASJC Scopus subject areas

  • Food Science
  • Pharmacology

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