Development and Validation of LC-MS/MS Method for Determination of an Antimigraine Naratriptan HCl in Human Plasma: An Application to a Pharmacokinetic Study
Received Date: Feb 26, 2020 / Accepted Date: Mar 10, 2020 / Published Date: Mar 18, 2020
A rapid sensitive and validated liquid chromatography/tandem mass spectrometry (LC-MS/MS) method is developed for determination of an antimigraine drug naratriptan (NAR) in human plasma using (alomtriptan) as internal standard (IS). a Liquid-liquid extraction with diethyl ether was used. The chromatographic separation was carried out using reversed phase C8 analytical Column (5 μm, 50 mm × 4.6 mm i.d.) with a simple isocratic mobile phase composed of methanol : 0.02 M ammonium formate (pH 3.5) (40:60 v/v) and flow rate 0.6 mLmin-1. Detection was performed on a triple quadrupole mass spectrometer employing electrospray ionization (ESI) technique, operating in multiple reaction monitoring (MRM), with the transitions of 336.3 → 98.2 and 336.3 → 201.0 m/z for NAR and IS, respectively in the positive ion mode. The analysis was carried out within 2.4 min over a linear concentration range of 0.05-20 ngmL-1. The method was validated according to the FDA bio-analytical method validation guidance for industry. The developed LC-MS/MS method was successfully applied to a pharmacokinetic study of the studied drug after being orally administered by Egyptian healthy volunteers.
Keywords: Formigran; Naratriptan HCl; Mass spectrometry; Pharmacokinetics; Bio-analytical Validation ; Liquid-Liquid extraction; Antimigraine
Citation: Ali M, Rizk M, Sultan MA, Elshahed MS (2020) Development and Validation of LC-MS/MS Method for Determination of an Naratriptan HCl in Human Plasma: An Application to a Pharmacokinetic Study. J Anal Bioanal Tech 11: 421. Doi: 10.4172/2155-9872.1000421
Copyright: © 2020 Ali M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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