Pharmacokinetics of pseudoephedrine in cetirizine sustained release tablets in human plasma

JIN Xiao-ling; GAO Shou-hong; WU Rong

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Objective To establish a LC-MS/MS method for the determination of pseudoephedrine concentration in plasma, and to investigate the pharmacokinetics of sustained release tablets of cetirizine hydrochloride and pseudoephedrine hydrochloride in Chinese healthy volunteers. Methods The plasma concentrations of pseudoephedrine were determined by LC-MS/MS method in the volunteers at different time points. Amantadine hydrochloride was used as internal standard. After precipitation of the plasma proteins with acetonitrile, the analytes were separated on an agilent zorbax SB-C₁₈ reversed-phase column with methanol -0.1% formic acid (40:60, v/v) and detected by electrospray ionization (ESI) mass spectrometry in positive multiple reaction monitoring (MRM) mode. The flow rate was 0.3 ml/min. Column temperature was maintained at 30 ℃. Results The calibration curves with good linearities (r=0.995 2 for plasma sample) were obtained in the range of 2.5~1 000.0 ng/ml for pseudoephedrine. The lower limit of quantification (LLOQ) was 2.5 ng/ml. Recoveries were around 78% for the extraction from human plasma, and good precision and accuracy were achieved. The intra-day and inter-day RSD were less than 15.0%. Conclution This method was simple, selective and sensitive. It's suitable for the pharmacokinetic research of pseudoephedrine in human plasma.

Pharmacokinetics of pseudoephedrine in cetirizine sustained release tablets in human plasma

Department of Pharmacy, Changzheng Hospital, Second Military Medical University, Shanghai 200003, China

Received Date: 2011-08-17

Rev Recd Date: 2011-09-08

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Abstract: Objective To establish a LC-MS/MS method for the determination of pseudoephedrine concentration in plasma, and to investigate the pharmacokinetics of sustained release tablets of cetirizine hydrochloride and pseudoephedrine hydrochloride in Chinese healthy volunteers. Methods The plasma concentrations of pseudoephedrine were determined by LC-MS/MS method in the volunteers at different time points. Amantadine hydrochloride was used as internal standard. After precipitation of the plasma proteins with acetonitrile, the analytes were separated on an agilent zorbax SB-C₁₈ reversed-phase column with methanol -0.1% formic acid (40:60, v/v) and detected by electrospray ionization (ESI) mass spectrometry in positive multiple reaction monitoring (MRM) mode. The flow rate was 0.3 ml/min. Column temperature was maintained at 30 ℃. Results The calibration curves with good linearities (r=0.995 2 for plasma sample) were obtained in the range of 2.5~1 000.0 ng/ml for pseudoephedrine. The lower limit of quantification (LLOQ) was 2.5 ng/ml. Recoveries were around 78% for the extraction from human plasma, and good precision and accuracy were achieved. The intra-day and inter-day RSD were less than 15.0%. Conclution This method was simple, selective and sensitive. It's suitable for the pharmacokinetic research of pseudoephedrine in human plasma.

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Reference (8)

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Pharmacokinetics of pseudoephedrine in cetirizine sustained release tablets in human plasma

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