Objective:To determine sulpiride in human
plasma with the
method of HPLC,and study its pharmacokinetics,relative bioavailability.Method:A solid-phase extraction and reversed-phase
high performance liquid chromatography method was used,and metoclopramide was applied as internal standard,mobile
phase was set as acetonitril and 5 mmol/L KH_2PO_4(45∶55,V/V),and wavelength, λex 244 nm,λem 280 nm.Eighteen volunteers were randomized into two groups.Group one first received the trial
preparation sulpiride tablets,and then was followed with the reference preparation.Group two received the reference preparation first,and was followed with the trial preparation.Plasma concentration of sulpiride was measured by HPLC method.ANOVA was used to check the difference of the
pharmacokinetic parameters between the two preparations.Bioequivalence was determined by two one-sided t-tests.Results:The standard curves were linear within the range 6.76～1 689.6 ng·mL~(-1) for sulpiride in plasma,the regression equation was A/A_(IS)=0.00289079×Conc.+0.00247349(r=0.9998,n=9).The recovery averaged between 90%～110%.The mean inter-and intra-assay coefficients variation was less than 5%.The pharmacokinetic parameters,AUC_(0→36),AUC_(0→∞),T_(max),C_(max) and t_(1/2) of the volunteers after taking a single dose of 100 mg of the trial preparation or the comparison preparation were((3 996.0)±579.5)(ng·h·mL~(-1)) &(3 939.6±469.7) ng·h·mL~(-1),(4 715.5±753.2) ng·h·mL~(-1) &(4 629.7±773.2) ng·h·mL~(-1),(3.3±0.8) h &(2.7±1.0) h,(362.9±118.7) ng·mL~(-1) and(358.9±98.9) ng·mL~(-1),(10.3±3.8) h &(9.7±4.1) h,respectively.The relative
bioavailability was 101.9%±13.7%.Conclusions:The methods can determine sulpiride in the human plasma quickly and correctly and the two preparations are equivalent.
More abstracts about the HPLC determination of sulpiride in human plasma and its pharmacokinetic,and relative bioavailability