Transl Clin Pharmacol.  2017 Jun;25(2):106-111. 10.12793/tcp.2017.25.2.106.

Determination of sumatriptan in human plasma using liquid chromatography-mass spectrometry for pharmacokinetic study in healthy Korean volunteers

• Cho S
• Jegal M
• Ohk B
• Kim BK
• Gwon MR
• Kang WY
• Seong SJ
• Kim HJ
• Lee HW
• Yoon YR

• KMID: 2386768
• DOI: http://doi.org/10.12793/tcp.2017.25.2.106

Abstract

This study describes the development of an analytical method to determine sumatriptan levels in human plasma using high performance liquid chromatography (HPLC) coupled with triple quadrupole tandem mass spectrometry (MS/MS) and its application to a pharmacokinetic study in healthy Korean volunteers. A single 50 mg dose of sumatriptan was orally administered to twelve healthy volunteers (nine women and three men). The HPLC-MS/MS analytical method was validated with respect to its specificity, linearity, sensitivity, accuracy, precision, recovery, and stability. The calibration curve was linear over a concentration range of 0.3-100 ng/mL (r > 0.999). The lower limit of quantitation for sumatriptan in plasma was 0.3 ng/mL. The accuracy and precision of the analytical method were acceptable within 15% at all quality control levels. We compared plasma concentration-time curves as well as pharmacokinetic parameters such as the area under the curve (AUC) and maximum plasma concentration (C(max)). Both the mean AUC and C(max) of sumatriptan were 1.56 times higher in women than in men. These differences could be largely explained by the difference in body weight (44%) between women and men. The outcomes may provide insights into developing appropriate individualized treatment strategies.

Keyword

Sumatriptan; HPLC-MS/MS; Pharmacokinetic study; Human plasma; Method validation

MeSH Terms

Area Under Curve
Body Weight
Calibration
Chromatography, Liquid
Female
Healthy Volunteers
Humans*
Male
Methods
Plasma*
Quality Control
Sensitivity and Specificity
Spectrum Analysis*
Sumatriptan*
Tandem Mass Spectrometry
Volunteers*
Sumatriptan

Figure

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  Figure 1 Mean plasma concentration-time profiles of sumatriptan after single oral dose 50-mg sumatriptan for nine female (blue open circle) and three male (red closed circle) healthy volunteers. Shaded areas with error bars represent standard deviation from the mean value.

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