Application of HPLC Method Using Normal Phase Column in a Comparative Pharmacokinetic Study of Two Sulpiride Tablet Formulations
MING-CHUAN HUANG 1, HSIU-O HO 1, GENG-CHENG YEH 2, WEN-TING KE 1,3, LI-CHIN LIN 4, T-M BRUCE HSU 4 AND MING-THAU SHEU 1*
1. Graduate Institute of Pharmaceutical Sciences and 2.Department of Pediatrics, Taipei Medical University, 250 Wu-Hsing Street, Taipei, Taiwan, R.O.C.
3. Taiwan Biopharmtech Co., Ltd., Taipei, Taiwan, R.O.C.
4. Sin-Tong Chemical Industrial Co., Ltd., Taoyuan, Taiwan, R.O.C.
(Received: June 5, 2001; Accepted: January 11, 2002)
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, AUC0-last, AUC0-inf, and Cmax, 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: sulpiride, normal phase column, bioequivalence, HPLC