title: Development and validation of a liquid chromatography-tandem mass spectrometry method for the simultaneous determination of acrivastine and pseudoephedrine in human plasma and its application in pharmacokinetics.
abstract: A specific, sensitive and accurate liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed for the simultaneous determination of acrivastine and pseudoephedrine in human plasma samples. Plasma samples were processed and analyzed on a Phenomenex Luna 3 μ CN 100A column (150 mm×2.0 mm) eluted with the mobile phase consisting of methanol and 0.01 mol/L ammonium acetate water solution containing 0.1% formic acid (45:55, v/v) at a flow rate of 0.2 mL/min. The analytes were detected by positive ion electrospray ionization in multiple reaction monitoring mode. The transitions of m/z 349→278, m/z 166→148 and m/z 256→167 were monitored for acrivastine, pseudoephedrine and diphenhydramine (IS), respectively. The method was specific and sensitive with a lower limit of quantitation (LLOQ) of 1.52 ng/mL for acrivastine and 8.13 ng/mL for pseudoephedrine. The method showed good linearity in the range of 1.52~606.0 0 ng/mL for acrivastine and 8.13~813.12 ng/mL for pseudoephedrine (r≥0.996). The mean recovery were ranged 91.82% ~ 98.46% for acrivastine and 90.77% ~ 92.05% for pseudoephedrine. Validation results, such as accuracy, precision and repeatability were within the required limits. The method was successfully applied in a pharmacokinetic study of the acrivastine and pseudoephedrine hydrochloride compound capsule in humans.
authors.affiliation: Department of Pharmacy, Kunming General Hospital of Chengdu Military Command, Kunming, Yunnan, PR China.
authors.forename: J-C
authors.initials: JC
authors.lastname: He
authors.forename: E-F
authors.initials: EF
authors.lastname: Feng
authors.forename: M
authors.initials: M
authors.lastname: Liu
authors.forename: H-L
authors.initials: HL
authors.lastname: Li
authors.forename: M
authors.initials: M
authors.lastname: Tian
authors.forename: Q
authors.initials: Q
authors.lastname: Zhang
authors.forename: L-C
authors.initials: LC
authors.lastname: Dong
authors.forename: G-L
authors.initials: GL
authors.lastname: Xu
mesh_terms: D001993:Bronchodilator Agents / Q000097:blood* / Q000493:pharmacokinetics; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000097:blood* / Q000493:pharmacokinetics; D006801:Humans; D057230:Limit of Detection; D008297:Male; D054199:Pseudoephedrine / Q000097:blood* / Q000493:pharmacokinetics; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization; D053719:Tandem Mass Spectrometry; D014311:Triprolidine / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D055815:Young Adult
chemical_list: D001993:Bronchodilator Agents; D006634:Histamine H1 Antagonists; D014311:Triprolidine; D054199:Pseudoephedrine; C043648:acrivastine