AIMTo establish a sensitive and specific method to simultaneous determination of pseudoephedrine and chlorpheniramine in human plasma.

METHODSPseudoephedrine and chlorpheniramine were extracted from alkaline plasma with t-butyl methyl ether as the base form, and were back-extracted into 1.5% hydrochloride solution. The two drugs were simultaneous determined by RP-HPLC with ultraviolet detection at 200 nm, using dextromethorphan as internal standard. A C18 column (250 mm x 46 mm ID) and a mobile phase containing acetonitrile-water-triethylamine (46:54:0.2, containing 10 mmol x L(-1) sodium dodecyl sulfate (SDS) and 60 mmol x L(-1) NaH2 PO4, adjusted pH to 2.6 with H3PO4) were used.

RESULTSThe limit of quantification was 10.0 and 0.5 microg x L(-1), the linear range was 1.5 - 0.01 mg x L(-1) and 75 - 0.5 microg x L(-1), for pseudoephedrine and chlorpheniramine, respectively. The within-day and between-day RSD were less than 12.4%, and the average recovery was between 97.3% - 109.4%.

CONCLUSIONThe method was sensitive, specific, simple, and suitable for drug level monitoring in clinical pharmacokinetic study.