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Determination of Acotiamide in Human Plasma by LC-MS/MS and its Application to a Pharmacokinetic Study

[ Vol. 17 , Issue. 10 ]

Author(s):

Qian Sun, Yu-fei Yang, Qiao-gen Zou*, Yun-yan Xia and Cheng-qun Han   Pages 1249 - 1256 ( 8 )

Abstract:


Background: A liquid chromatography-tandem mass spectrometric (LC-MS/MS) method had been developed for the quantification of acotiamide in rat plasma and been applied to pharmacokinetic studies. However, there was no LC-MS/MS method been developed for the determination of acotiamide in human plasma and its pharmacokinetic study.

Objective: A simple and fast LC-MS/MS method was established and validated for the quantification of acotiamide in human Received: plasma and was applied to a pharmacokinetic study.

Methods: Sample preparation was accomplished Revised: Accepted: through protein precipitation, and chromatographic separation was achieved on a Welch, Ultimate XB-C18 column (2.1×50 mm, 3 μm) with a security guard cartridge C18 using a binary gradient with DOI: mobile phase A (Methanol) and B (the solution of 10 mM Ammonium acetate with 0.1% Formic acid) at a flow rate of 400 μL/min.

Results: The retention time of acotiamide and its internal standard, acotiamide-d6 was 1.78 min and 1.79 min, respectively. The total run time was 4.0 min. The method was developed and validated over the concentration range of 0.500-100 ng/mL for acotiamide, with correlation coefficient greater than 0.9987. The extraction recovery was more than 108.43% and the matrix effect was not significant. The inter- and intra-day precisions were below 5.80% and accuracies ranged from 92.7 to 103.0%. Acotiamide was demonstrated to be stable in human plasma under the tested conditions.

Conclusion: The validated LC-MS/MS method was successfully applied to study the pharmacokinetic profiles of acotiamide in human plasma after oral administration and has achieved satisfactory results.

Keywords:

Acotiamide, LC-MS/MS, human plasma, chromatographic separation, protein precipitation, pharmacokinetic.

Affiliation:

Department of Pharmaceutical Sciences, Nanjing Technology University, Nanjing210009, College of Biotechnology and Pharmaceutical Engineering, Nanjing Technology University, Nanjing210009, Department of Pharmaceutical Sciences, Nanjing Technology University, Nanjing210009, Department of Pharmaceutical Sciences, Nanjing Technology University, Nanjing210009, Department of Pharmaceutical Sciences, Nanjing Technology University, Nanjing210009

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