title: Development and validation of an improved method for the quantitation of sertraline in human plasma using LC-MS-MS and its application to bioequivalence studies.
abstract: A rapid and sensitive LC-MS-MS method for the quantitation of sertraline in human plasma was developed and validated. Sertraline and the internal standard, telmisartan, were cleaned up by protein precipitation from 100 μL of plasma sample, and analyzed on a TC-C18 column (5 μm, 150 × 4.6 mm i.d.) using 70% acetonitrile and 30% 10 mM ammonium acetate (0.1% formic acid) as mobile phase. The method was demonstrated to be linear from 0.1 ng/mL to 50 ng/mL with the lower limit of quantitation of 0.1 ng/mL. Intra- and inter-day precision were below 4.40% and 3.55%. Recoveries of sertraline at low, medium, and high levels were 88.0 ± 2.3%, 88.2 ± 1.9%, and 90.0 ± 2.0%, respectively. The method was successfully applied to a bioequivalence study of sertraline after a single oral administration of 50 mg sertraline hydrochloride tablets.
authors.affiliation: Research Center for Drug Metabolism, Jilin University, Changchun 130023, China.
authors.forename: Mengliang
authors.initials: M
authors.lastname: Zhang
authors.forename: Feng
authors.initials: F
authors.lastname: Gao
authors.forename: Xiangyong
authors.initials: X
authors.lastname: Cui
authors.forename: Yunhui
authors.initials: Y
authors.lastname: Zhang
authors.forename: Yantong
authors.initials: Y
authors.lastname: Sun
authors.forename: Jingkai
authors.initials: J
authors.lastname: Gu
mesh_terms: D000328:Adult; D001562:Benzimidazoles / Q000032:analysis / Q000737:chemistry; D001565:Benzoates / Q000032:analysis / Q000737:chemistry; D002853:Chromatography, Liquid / Q000379:methods*; D006801:Humans; D016014:Linear Models; D008297:Male; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D020280:Sertraline / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D053719:Tandem Mass Spectrometry / Q000379:methods*; D000077333:Telmisartan
chemical_list: D001562:Benzimidazoles; D001565:Benzoates; D020280:Sertraline; D000077333:Telmisartan