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

Fingerprint

Sulpiride
Tablets
pharmacokinetics
Pharmacokinetics
High Pressure Liquid Chromatography
Area Under Curve
Therapeutic Equivalency
dosage
Cross-Over Studies
volunteers
confidence interval
Volunteers
Linear Models
Software
Fluorescence
linear models
methodology
fluorescence
Confidence Intervals
water

Keywords

  • Bioequivalence
  • HPLC
  • Normal phase column
  • Sulpiride

ASJC Scopus subject areas

  • Food Science
  • Pharmacology

Cite this

Application of HPLC method using normal phase column in a comparative pharmacokinetic study of two sulpiride tablet formulations. / Huang, Ming Chuan; Ho, Hsiu O.; Yeh, Geng Cheng; Ke, Wen Ting; Lin, Li Chin; Hsu, T. M Bruce; Sheu, Ming Thau.

In: Journal of Food and Drug Analysis, Vol. 10, No. 1, 2002, p. 1-6.

Research output: Contribution to journalArticle

@article{ee22d9b2ee894d8880d1b2d23f8e1320,
title = "Application of HPLC method using normal phase column in a comparative pharmacokinetic study of two sulpiride tablet formulations",
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.",
keywords = "Bioequivalence, HPLC, Normal phase column, Sulpiride",
author = "Huang, {Ming Chuan} and Ho, {Hsiu O.} and Yeh, {Geng Cheng} and Ke, {Wen Ting} and Lin, {Li Chin} and Hsu, {T. M Bruce} and Sheu, {Ming Thau}",
year = "2002",
language = "English",
volume = "10",
pages = "1--6",
journal = "Journal of Food and Drug Analysis",
issn = "1021-9498",
publisher = "Elsevier Taiwan LLC",
number = "1",

}

TY - JOUR

T1 - Application of HPLC method using normal phase column in a comparative pharmacokinetic study of two sulpiride tablet formulations

AU - Huang, Ming Chuan

AU - Ho, Hsiu O.

AU - Yeh, Geng Cheng

AU - Ke, Wen Ting

AU - Lin, Li Chin

AU - Hsu, T. M Bruce

AU - Sheu, Ming Thau

PY - 2002

Y1 - 2002

N2 - 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.

AB - 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.

KW - Bioequivalence

KW - HPLC

KW - Normal phase column

KW - Sulpiride

UR - http://www.scopus.com/inward/record.url?scp=0036261960&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0036261960&partnerID=8YFLogxK

M3 - Article

VL - 10

SP - 1

EP - 6

JO - Journal of Food and Drug Analysis

JF - Journal of Food and Drug Analysis

SN - 1021-9498

IS - 1

ER -