METHODS AND OBJECTS OF CHEMICAL ANALYSIS ISSN title: "Metody i obʺekty himičeskogo analiza" An international journal devoted to all aspects of Analytical chemistry ISSN 2413-6166 (Online), ISSN 1991-0290 (Print)
		Ukr | En

Development and validation of LC-MS method with electro spray ionization for quantitation of sumatriptan in human plasma: Application to bioequivalence study

Dragana Rančić, Snežana Đorđević, Slavica Vučinić, Dragana Đorđević

Sumatriptan is a potent and selective vascular 5-hydroxytryptamine1 (5-HT1) receptor agonist effective for the treatment of migraine. We developed liquid chromatographic-mass spectrometric method for de-termination of sumatriptan in human plasma. Sumatriptan was extracted from samples using solid phase extraction technique and separated on analytical column, Waters ODS2, thermostated at 20°C.
The mobile phase was a mixture of 5mM ammonium-acetate and acetonitrile (80:20), with a flow rate of 0.3 mL/min. Total run time was 10 min. Mass spectral detector was optimized and adjusted in elec-trospray single ion monitoring (ESI-SIR) mode. Molecular ion masses (m/z) were 296.00 and 267.00 for sumatriptan and internal standard atenolol, respectively. Under these conditions retention times for inter-nal standard atenolol and sumatriptan, were 3.4 ± 0.3 min and 7.3 ± 0.5 min, respectively.
The standard curve of plasma spiked with sumatriptan was linear in the range of 1.0-100.0 ng/mL, with correlation coefficient r = 0.9931. The limit of quantification (LOQ) was 1.0 ng/mL. Presented method was successfully applied in the pharmacokinetic study of generic tablets with the new formulation, con-taining sumatriptan, after single oral dose (100 mg) was given to 24 volunteers.
This method is simple, sensitive and suitable for pharmacokinetic or bioequivalence studies.

Key words: Sumatriptan, LC-MS, plasma, bioequivalence study, vascular 5-hydroxytryptamine1 (5-HT1) receptor agonist