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Abstract
The study aimed to develop a sensitive and high-throughput liquid chromatography coupled with tandem mass spectrometry method to quantify concentrations of tramadol and paracetamol simultaneously in human plasma. Sample preparation involved single-step protein precipitation using methanol and two deuterated internal standards, tramadol D6 and paracetamol D4. Agilent Poroshell 120 EC-C18 (100 × 2.1 mm, 2.1 µm) analytical column was employed to achieve chromatographic separation. Detection was in positive ion multiple reaction monitoring mode. A tailing factor (Tf) of <1.2, separation factor (K prime) of >1.5 from the column dead time and signal-to-noise (S/N) ratio >10, were obtained for analytes and internal standards. The standard curve was linear over the concentration range of 2.5–500.00 ng/mL for tramadol and 0.025–20.00 μg/mL for paracetamol. A small injection volume of 1 µL, low flow rate of 440 µL/min and short analysis time of 3.5 min reduced the solvent consumption, analysis cost and system contamination. The results of method validation parameters fulfilled the acceptance criteria of bioanalytical guidelines. The method was successfully applied to a bioequivalence study of fixed-dose combination products of tramadol and paracetamol in Malaysian healthy subjects.
Acknowledgements
The Y.S.P. Industries (M) Sdn. Bhd. is acknowledged for providing test and reference products of the study.
Author contributions
Conceptualization: Gabriel Onn Kit Loh and Kok Khiang Peh. Data curation: Kok Khiang Peh and Long Chiau Ming. Formal analysis: Gabriel Onn Kit Loh, Emily Yii Ling Wong, Chen Zhu Goh, Yvonne Tze Fung Tan, Yi Lin Lee, Lai Hui Pang and Siti Halimah Shahridzo. Funding acquisition: Long Chiau Ming, Andi Hermansyah and Kok Khiang Peh. Investigation: Nair Damenthi and Kok Khiang Peh. Methodology: Gabriel Onn Kit Loh, Emily Yii Ling Wong, Chen Zhu Goh, Yvonne Tze Fung Tan, Yi Lin Lee, Lai Hui Pang, Siti Halimah Shahridzo and Kok Khiang Peh. Project administration: Gabriel Onn Kit Loh, Yi Lin Lee, Lai Hui Pang, Siti Halimah Shahridzo and Nair Damenthi. Resources: Nair Damenthi and Kok Khiang Peh. Software: Long Chiau Ming, Andi Hermansyah and Kok Khiang Peh. Supervision: Nair Damenthi and Kok Khiang Peh. Validation, Gabriel Onn Kit Loh, Emily Yii Ling Wong and Chen Zhu Goh. Visualization: Nair Damenthi and Kok Khiang Peh. Writing – original draft, Gabriel Onn Kit Loh, Emily Yii Ling Wong and Kok Khiang Peh. Writing – review and editing, Long Chiau Ming Andi Hermansyah and Kok Khiang Peh.
Disclosure statement
The authors declare no conflict of interest.
Correction Statement
This article has been corrected with minor changes. These changes do not impact the academic content of the article.