Development of a Simple and Validated LC-MS/MS Method for Quantitative Determination of Ketotifen in Beagle Dog Plasma and Its Application to Bioequivalence Study of Ketotifen Syrup Dosage Form.

ABSTRACT: A highly accurate, precise, and simple liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for ketotifen (KTF) estimation from Beagle dog plasma was developed and validated, with ketotifen-d3 (KTF-d3) as the internal standard (IS). KTF and IS were detected on an API 4000 mass spectrometer in multiple reaction monitoring (MRM) mode in electrospray ionization (ESI) positive ionization mode. The transitions were monitored at m/z 310.2 → 96.0 for KTF and m/z 313.2 → 99.1 for IS. KTF and IS were extracted from plasma using liquid-liquid extraction with methyl tertiary-butyl ether and then analyzed for 3 min with extracted samples (7 µL) into the LC-MS/MS system. Analytes were separated on a Luna^® Hilic column (50 × 2.0 mm i.d., 3 μm) using the Nexera X2 HPL

SUBMITTER: Song E 

PROVIDER: S-EPMC11433888 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature