Determination of Acotiamide in Human Plasma by LC-MS/MS and its Application to a Pharmacokinetic Study
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Published:2021-12
Issue:10
Volume:17
Page:1249-1256
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ISSN:1573-4129
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Container-title:Current Pharmaceutical Analysis
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language:en
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Short-container-title:CPA
Author:
Sun Qian1,
Yang Yu-fei2,
Zou Qiao-gen1ORCID,
Xia Yun-yan1ORCID,
Han Cheng-qun1
Affiliation:
1. Department of Pharmaceutical Sciences, Nanjing Technology University, Nanjing210009, China
2. College of Biotechnology and Pharmaceutical Engineering, Nanjing Technology University, Nanjing210009, China
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.
Publisher
Bentham Science Publishers Ltd.
Subject
Pharmaceutical Science,Molecular Medicine,Biochemistry,Biophysics