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© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

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 HPLC. The mobile phase A consisted of 10 mmol/L ammonium formate (pH 3.0), while mobile phase B consisted of 0.05% formic acid in acetonitrile. The ratio of mobile phase was 5:95 (v/v) at a flow rate of 0.2 mL/min. The method has been thoroughly validated in accordance with the bioanalytical method validation guidelines established by the Ministry of Food and Drug Safety in Korea and the U.S. Food and Drug Administration, addressing selectivity, lower limit of quantification, linearity, carryover, precision, accuracy, recovery, matrix effect, and stability. The developed LC–MS/MS method was effectively utilized for the bioequivalence assessment of ketotifen in Beagle dog plasma following the oral administration of ketotifen syrup.

Details

Title
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
Author
Song, Eunseo 1   VIAFID ORCID Logo  ; Wang-Seob Shim 2   VIAFID ORCID Logo  ; Choi, Doowon 1 ; Song, Yuna 1 ; Hyeong Geun Jo 3 ; Lee, Soobok 4 ; Suk Han Jung 5 ; Yeo Jin Choi 6   VIAFID ORCID Logo  ; Lee, Kyung-Tae 1   VIAFID ORCID Logo 

 Department of Biomedical and Pharmaceutical Science, Graduated School, Kyung Hee University, Seoul 02447, Republic of Korea; [email protected] (E.S.); [email protected] (D.C.); [email protected] (Y.S.); Kyung Hee Drug Analysis Center, College of Pharmacy, Kyung Hee University, Seoul 02447, Republic of Korea; [email protected]; Department of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul 02447, Republic of Korea 
 Kyung Hee Drug Analysis Center, College of Pharmacy, Kyung Hee University, Seoul 02447, Republic of Korea; [email protected] 
 Daewon Pharm. Co., Ltd., 386 Cheonhodae-ro, Gwangjin-gu, Seoul 04808, Republic of Korea; [email protected] (H.G.J.); [email protected] (S.L.); [email protected] (S.H.J.) 
 Daewon Pharm. Co., Ltd., 386 Cheonhodae-ro, Gwangjin-gu, Seoul 04808, Republic of Korea; [email protected] (H.G.J.); [email protected] (S.L.); [email protected] (S.H.J.); Department of Regulatory Science, Graduated School, Kyung Hee University, Seoul 02447, Republic of Korea 
 Daewon Pharm. Co., Ltd., 386 Cheonhodae-ro, Gwangjin-gu, Seoul 04808, Republic of Korea; [email protected] (H.G.J.); [email protected] (S.L.); [email protected] (S.H.J.); Department of Fundamental Pharmaceutical Science, Graduated School, Kyung Hee University, Seoul 02447, Republic of Korea 
 Department of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul 02447, Republic of Korea 
First page
4505
Publication year
2024
Publication date
2024
Publisher
MDPI AG
e-ISSN
14203049
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3110654381
Copyright
© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.