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

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

Volume: 17 Issue: 10

Author(s): Qian Sun, Yu-fei Yang, Qiao-gen Zou*, Yun-yan Xia and Cheng-qun Han

Affiliation:

• Department of Pharmaceutical Sciences, Nanjing Technology University, Nanjing210009,China

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

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.

Cite this article as:

Sun Qian , Yang Yu-fei , Zou Qiao-gen *, Xia Yun-yan and Han Cheng-qun , Determination of Acotiamide in Human Plasma by LC-MS/MS and its Application to a Pharmacokinetic Study, Current Pharmaceutical Analysis 2021; 17 (10) . https://dx.doi.org/10.2174/1573412917999201110203650