US EPA

1054198 

Journal Article 

Simultaneous determination of paracetamol, pseudoephedrine, dextrophan and chlorpheniramine in human plasma by liquid chromatography-tandem mass spectrometry 

Lou, HG; Yuan, H; Ruan, ZR; Jiang, B 

2010 

Yes 

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
ISSN: 1570-0232
EISSN: 1873-376X 

878 

7-8 

682-688 

English 

20133213 

10.1016/j.jchromb.2010.01.005 

WOS:000275565200009 

For the first time, a highly sensitive and simple LC-MS/MS method after one-step precipitation was developed and validated for the simultaneous determination of paracetamol (PA), pseudoephedrine (PE), dextrophan (DT) and chlorpheniramine (CP) in human plasma using diphenhydramine as internal standard (IS). The analytes and IS were separated on a YMC-ODS-AQ C(18) Column (100 mm x 2.0 mm, 3 microm) by a gradient program with mobile phase consisting of 0.3% (v/v) acetic acid and methanol at a flow rate of 0.30 mL/min. Detection was performed on a triple quadrupole tandem mass spectrometer via electrospray ionization in the positive ion mode. The method was validated and linear over the concentration range of 10-5000 ng/mL for PA, 2-1000 ng/mL for PE, 0.05-25 ng/mL for DT and 0.1-50 ng/mL for CP. The accuracies as determined from quality control samples were in range of -8.37% to 3.13% for all analytes. Intra-day and inter-day precision for all analytes were less than 11.54% and 14.35%, respectively. This validated method was successfully applied to a randomized, two-period cross-over bioequivalence study in 20 healthy Chinese volunteers receiving multicomponent formulations containing 325 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride, 15 mg of dextromethorphan hydrobromide and 2 mg of chlorphenamine maleate. 

Paracetamol; Pseudoephedrine; Dextrophan; Chlorpheniramine; LC-MS/MS; Bioequivalence