2. Academic Validation
  3. Development of a UHPLC-MS/MS method for the quantification of Pristinamycin ⅠA and ⅡA in beagle dog plasma and its pharmacokinetic application

Development of a UHPLC-MS/MS method for the quantification of Pristinamycin ⅠA and ⅡA in beagle dog plasma and its pharmacokinetic application

  • J Pharm Biomed Anal. 2024 Dec 15:251:116401. doi: 10.1016/j.jpba.2024.116401.
Tao Ke 1,  Zhongyuan Zhao 2,  Junhuan Lin 3,  Fengting Ou 4,  Kaikai Chen 2,  Kui Zeng 4,  Debo He 5,  Shengqiang Tong 1,  Xinyi Wang 1,  Lushan Yu 6,  Jing Chen 7
Affiliations

Affiliations

  • 1 Collaborative Innovation Center of Yangtze River Delta Region Green Pharmaceuticals, Zhejiang University of Technology, Hangzhou 310014, China.
  • 2 Research and Development Center, Zhejiang Medicine Co. Ltd., Shaoxing 312000, China.
  • 3 Jinhua Institute of Zhejiang University, Jinhua 321036, China; State Key Laboratory of Advanced Drug Delivery and Release Systems, Zhejiang University, Hangzhou 310058, China; Institute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
  • 4 Jinhua Institute of Zhejiang University, Jinhua 321036, China.
  • 5 State Key Laboratory of Advanced Drug Delivery and Release Systems, Zhejiang University, Hangzhou 310058, China; Institute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
  • 6 Jinhua Institute of Zhejiang University, Jinhua 321036, China; State Key Laboratory of Advanced Drug Delivery and Release Systems, Zhejiang University, Hangzhou 310058, China; Institute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China. Electronic address: yuls@zju.edu.cn.
  • 7 Research and Development Center, Zhejiang Medicine Co. Ltd., Shaoxing 312000, China. Electronic address: chenjing@zmc.top.
PMID: 39151292 DOI: 10.1016/j.jpba.2024.116401
Abstract

The aim of this study was to develop and fully validate a sensitive and rapid ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method for simultaneous quantification of pristinamycin ⅠA (PⅠA) and pristinamycin ⅡA (PⅡA) in plasma of beagle dogs after oral administration of pristinamycin tablets. PⅠA, PⅡA and quinupristin (internal standard, IS) were separated on an Agilent Eclipse Plus C18 column (2.1 mm × 100 mm, 3.5 μm particle size) by using gradient elution consisting of methanol and water (0.1 % formic acid) at a flow rate of 0.4 mL/min in 4.0 min. Multiple reaction monitoring (MRM) mode was performed to quantify data under monitoring precursor-product ion transitions of m/z 867.6→134.1, 548.4→287.1 and 1022.7→133.9 for PⅠA, PⅡA and IS at positive ion mode, respectively. The method was developed at linearity ranging from 1.0 to 1000 ng/mL for all analytes.The accuracy of PⅠA and PⅡA was observed to range between -10.6 % and 7.1 %, while the precision was found to be within 8.9 %. No significant matrix effect was observed. PⅠA and PⅡA demonstrated stability during sample storage, preparation and analytic procedures. Furthermore, this method was successfully applied in the investigation of the pharmacokinetic profile of PⅠA and PⅡA in beagle dogs after oral administration of pristinamycin tablets (75 mg for PⅠA and 175 mg for PⅡA). The biological half-life (t1/2) was determined to be 1.75 ± 0.07 h and 1.44 ± 0.31 h for PⅠA and PⅡA, respectively. The areas under curves (AUC0-t) of PⅠA and PⅡA were 80.7 ± 24.6 and 230 ± 94.8 μg/L·h, respectively.

Keywords

Beagle dog plasma; Pharmacokinetics; Pristinamycin; UHPLC-MS/MS.

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