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Open AccessArticle

Development and Validation of Liquid Chromatography-Tandem Mass Spectrometry Method for Simple Analysis of Sumatriptan and its Application in Bioequivalence Study

1
Department of Bioanalytical Development, Pharma Nueva Co., Ltd., Bangkok 10900, Thailand
2
Natural Products for Ageing and Chronic Diseases Research Unit, Chulalongkorn University, Bangkok 10330, Thailand
3
Department of Clinical Development, Pharma Nueva Co., Ltd., Bangkok 10900, Thailand
4
Department of Food and Pharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10330, Thailand
*
Author to whom correspondence should be addressed.
Pharmaceuticals 2020, 13(2), 21; https://doi.org/10.3390/ph13020021
Received: 5 January 2020 / Revised: 18 January 2020 / Accepted: 20 January 2020 / Published: 24 January 2020
(This article belongs to the Section Pharmaceutical Technology)
This work demonstrated a sensitive, selective, and simple liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for quantitation of sumatriptan in human plasma samples. Terazosin was used as an internal standard to minimize the variability during sample processing and detection. Sample cleanup prior to chromatographic analysis was accomplished by liquid-liquid extraction (LLE) with tert-butyl methyl ether (t-BME). The separation was performed on a reversed-phase Symmetry® C18 column (150 × 4.6 mm i.d., 5 µm) under a gradient mode, using a 0.2% formic acid aqueous solution and acetonitrile at a flow rate of 0.5 mL/min. Sumatriptan (m/z 296.26→251.05) and terazosin (m/z 388.10→290.25) were quantified using a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring (MRM) under the positive ion mode. The method was fully validated following US-FDA and EMA guidelines. The LC-MS/MS assay had a calibration range of 0.5–50.0 ng/mL. The assay was precise and accurate with a between-run precision of <9.51%, and between-run accuracy between −7.27 to 8.30%. The developed method was subsequently applied in the determination of plasma concentration-time profile of a sumatriptan 50-mg tablet following oral administration in healthy volunteers. View Full-Text
Keywords: sumatriptan; LC-MS/MS; liquid-liquid extraction; pharmacokinetics; bioequivalence sumatriptan; LC-MS/MS; liquid-liquid extraction; pharmacokinetics; bioequivalence
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Wichitnithad, W.; Nantaphol, S.; Vicheantawatchai, P.; Kiatkumjorn, T.; Wangkangwan, W.; Rojsitthisak, P. Development and Validation of Liquid Chromatography-Tandem Mass Spectrometry Method for Simple Analysis of Sumatriptan and its Application in Bioequivalence Study. Pharmaceuticals 2020, 13, 21.

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