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An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study

  
@article{APS6425,
	author = {Gan Zhou and Zhi-rong Tan and Wei Zhang and Dong-sheng Ou-Yang and Yao Chen and Dong Guo and Ying-zi Liu and Lan Fan and Han-wu Deng},
	title = {An improved LC-MS/MS method for quantitative determination of ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study},
	journal = {Acta Pharmacologica Sinica},
	volume = {30},
	number = {9},
	year = {2016},
	keywords = {},
	abstract = {Aim: To improve and validate an analytical method based on liquid chromatography and electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) for the quantitative measurement of ilaprazole and its two metablites in human plasma.
Methods: Separation of analytes and the internal standard (IS), omeprazole, was performed on a Thermo HyPURITY C18 column (150×2.1 mm, 5 μm) with a mobile phase consisting of 10 mmol/L ammonium formate water-acetonitrile solution (50:50, v/v) at a flow rate of 0.25 mL/min. The API4000 triple quadruple mass spectrometer was operated in multiple reactions monitoring mode via positive electrospray ionization interface using the transition m/z 367.2 → m/z184.0 for ilaprazole,m/z 383.3 → m/z 184.1 for ilaprazole sulfone, m/z 351.2 → m/z 168.1 for ilaprazole thiol ether and m/z 346.2 → m/z 198.0 for omeprazole.
Results: The method was linear over the concentration range of 0.23−2400.00 ng/mL for ilaprazole, 0.05−105.00 ng/mL for ilaprazole thiol ether and 0.06−45.00 ng/mL for ilaprazole sulfone. The intra- and inter-day precisions were all less than 15% in terms of relative standard deviation (RSD), and the accuracy was within 15% in terms of relative error (RE) for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether. The lower limit of quantification (LLOQ) was identifiable and reproducible at 0.23, 0.05 and 0.06 ng/mL with acceptable precision and accuracy for ilaprazole, ilaprazole sulfone and ilaprazole thiol ether, respectively.
Conclusion: The validated method offered sensitivity and a wide linear concentration range. This method was successfully applied for the evaluation of the pharmacokinetics of ilaprazole and its two metabolites after single oral doses of 5 mg ilaprazole to 12 healthy Chinese volunteers.},
	issn = {1745-7254},	url = {http://www.chinaphar.com/article/view/6425}
}