Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume 45,
Number 3, March 2007, pp.158-165
High-Performance Liquid Chromatography–Electrospray
Ionization-Mass Spectrometric Determination of Emedastine Difumarate
in Human Plasma and Its Pharmacokinetics
Yuan Tian[1,2], Zunjian Zhang[1,2], Jiabi Liang[1,2],
Wei Li[1,2], and Yun Chen[3]
[1]Key Laboratory of Drug Quality Control and Pharmacovigilance,
China Pharmaceutical University, Ministry of Education;
[2]Center for Instrumental Analysis, China Pharmaceutical University,
Nanjing, Jiangsu 210009, P.R. China; and
[3]Dermatology, Chinese Academy of Medical Sciences & Perking
Union Medical College, Nanjing, Jiangsu 210042, P.R. China
A selective and sensitive method employing high-performance
liquid chromatography (HPLC)–electrospray ionization (ESI)-mass
spectrometry is developed and validated for the determination
of emedastine difumarate in human plasma. With naphazoline hydrochloride
as the internal standard, emedastine difumarate is extracted from
plasma with ethyl acetate. The organic layer is evaporated, and
the residue is redissolved in the mobile phase. An aliquot of
10 µL is chromatographically analyzed on a prepacked Phenomenex
Luna 5u CN 100A (150 ¥ 2.0-mm i.d.) column, using a mobile
phase comprised of methanol–water (20mM CH3COONH4, pH 4.0)
(80:20, v/v). Standard curves are linear (r2 = 0.9990) over the
concentration range of 0.05–30 ng/mL and had good accuracy
and precision. The within- and between-batch precisions did not
exceed 15% for the relative standard deviation. The lower limit
of detection is 0.01 ng/mL. The validated HPLC–ESI-MS method
is successfully used to study emedastine difumarate pharmacokinetics
in 12 healthy volunteers.
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