Simultaneous determination of concentration of sulfamethoxazole and trimethoprim in human plasma by dual-quaternary HPLC and its clinical application

Abstract

Sulfamethoxazole compound, a combination of sulfamethoxazole and trimethoprim, is commonly prescribed to organ transplant recipients for infections caused by Nocardia, Burkholderia cepacia, and Pneumocystis jirovecii. The intricate pharmacokinetics and pharmacodynamics of this compound pose challenges in achieving optimal therapeutic drug levels. Therefore, monitoring the plasma concentration of this compound drug is necessary. To address this need, we have developed a rapid and straightforward dual-quaternary two-dimensional high-performance liquid chromatography (2D-HPLC) method for the simultaneous quantification of sulfamethoxazole and trimethoprim. This technique involves a one-step protein precipitation procedure, with the initial stage utilizing a solid-phase extraction column followed by an analytical column for the subsequent stage. Detection is achieved using a dual-quaternary 2D-HPLC system. Calibration curves for both sulfamethoxazole and trimethoprim were constructed, and the method underwent thorough validation in accordance with the Chinese Pharmacopoeia (Ch.P) standards, demonstrating remarkable accuracy and precision. This technique has been effectively employed for routine therapeutic drug monitoring (TDM) in organ transplant patients and other individuals requiring medical intervention.

Keywords

Dual-quaternary two-dimensional liquid chromatography system / Compound sulfamethoxazole / Therapeutic drug monitoring (TDM) / Organ transplant recipients

Declarations

Not applicable.

Authors' contributions

L. Nong: Writing - original draft, Methodology, Funding acquisition, Formal analysis. Y. Tang: Writing - review & editing, Validation, Conceptualization. X. Qin: Writing - review & editing, Investigation. Z. Zhou: Data curation. Z. Lai and W. Wei: Resources, Supervision, Project administration. W. Tan: Writing - review & editing, Supervision.

Ethics approval and consent to participate

The study was approved by the Ethics Committee of The Second Affiliated Hospital of Guangxi Medical University (2024 Scientific Research Ethics Review No. 23). All procedures involving human participants were conducted in accordance with the ethical standards set by the institutional and national research committees and with the 1964 Helsinki Declaration and its subsequent amendments or comparable ethical standards. Informed consent was obtained from the participant’s legal guardian before treatment.

Consent for publication

Written informed consent for publication was obtained from all participants.

Availability of data and materials

Data will be made available on request.

Funding

This study was supported by Guangxi Natural Science Foundation Joint Special Project on Regional High-Prevalence Disease Research (No. 2024GXNSFBA010188), Self-funded Scientific Research Project of Guangxi Autonomous Region Health Commission (No. Z-A20230643) and Self-funded Scientific Research Project of Guangxi Autonomous Region Health Commission (No. Z-A20240649).

Declaration of Competing Interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Acknowledgements

Not applicable.

Authors' other information

Not applicable.

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