E-ISSN 0976-2779 | ISSN 0975-8453
 

Review Article 


Development, Validation, and Application for Simultaneous Assay of Metformin and Sitagliptin in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry

Nguyen Ngoc Nha Thao, Nguyen Ngoc Hieu, Do Chau Minh Vinh Tho, Trinh Thi Thu Loan, Nguyen Duc Tuan.

Abstract
Background: The objective of this study was to develop a liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for the determination of metformin and sitagliptin in human plasma and to apply this method for bioequivalence study.
Methods: An LC–MS/MS method was developed, validated, and applied to the quantification of metformin and sitagliptin in human plasma. Phenformin was used as an internal standard. LC–MS/MS with electrospray ionization (ESI) in positive ion mode, performed under the multiple reaction monitoring (MRM) mode, was used for analysis of the analytes.
Results: The method was developed and validated with respect to selectivity and carryover, as well as intra- and inter-day accuracy and precision, according to the United States Food and Drug Administration guidance. Analytes were extracted from human plasma by a protein precipitation technique using methanol after acidification with formic acid. The mean extraction recovery for the analytes was between 70% and 99.95%, and matrix effects had only a minor influence on precision.
Conclusion: The validated method was applied for a clinical bioequivalence study to evaluate the in vivo bioequivalence of a product containing 500 mg metformin hydrochloride and 50 mg sitagliptin and the Janumet XR® 50/500 mg commercial product. Fourteen healthy subjects participated in this randomized, two-period, two-treatment, open label, crossover-design study. Standard pharmacokinetic parameters were calculated to compare the test product to the commercially available Janumet XR® 50/500 mg reference product.

Key words: bioequivalence; Human plasma; LC-MS/MS; Metformin; sitagliptin


 
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How to Cite this Article
Pubmed Style

Nguyen Ngoc Nha Thao, Nguyen Ngoc Hieu, Do Chau Minh Vinh Tho, Trinh Thi Thu Loan, Nguyen Duc Tuan. Development, Validation, and Application for Simultaneous Assay of Metformin and Sitagliptin in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry. SRP. 2020; 11(2): 6-13. doi:10.5530/srp.2020.2.02


Web Style

Nguyen Ngoc Nha Thao, Nguyen Ngoc Hieu, Do Chau Minh Vinh Tho, Trinh Thi Thu Loan, Nguyen Duc Tuan. Development, Validation, and Application for Simultaneous Assay of Metformin and Sitagliptin in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry. http://www.sysrevpharm.org//?mno=83803 [Access: March 28, 2020]. doi:10.5530/srp.2020.2.02


AMA (American Medical Association) Style

Nguyen Ngoc Nha Thao, Nguyen Ngoc Hieu, Do Chau Minh Vinh Tho, Trinh Thi Thu Loan, Nguyen Duc Tuan. Development, Validation, and Application for Simultaneous Assay of Metformin and Sitagliptin in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry. SRP. 2020; 11(2): 6-13. doi:10.5530/srp.2020.2.02



Vancouver/ICMJE Style

Nguyen Ngoc Nha Thao, Nguyen Ngoc Hieu, Do Chau Minh Vinh Tho, Trinh Thi Thu Loan, Nguyen Duc Tuan. Development, Validation, and Application for Simultaneous Assay of Metformin and Sitagliptin in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry. SRP. (2020), [cited March 28, 2020]; 11(2): 6-13. doi:10.5530/srp.2020.2.02



Harvard Style

Nguyen Ngoc Nha Thao, Nguyen Ngoc Hieu, Do Chau Minh Vinh Tho, Trinh Thi Thu Loan, Nguyen Duc Tuan (2020) Development, Validation, and Application for Simultaneous Assay of Metformin and Sitagliptin in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry. SRP, 11 (2), 6-13. doi:10.5530/srp.2020.2.02



Turabian Style

Nguyen Ngoc Nha Thao, Nguyen Ngoc Hieu, Do Chau Minh Vinh Tho, Trinh Thi Thu Loan, Nguyen Duc Tuan. 2020. Development, Validation, and Application for Simultaneous Assay of Metformin and Sitagliptin in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry. Systematic Reviews in Pharmacy, 11 (2), 6-13. doi:10.5530/srp.2020.2.02



Chicago Style

Nguyen Ngoc Nha Thao, Nguyen Ngoc Hieu, Do Chau Minh Vinh Tho, Trinh Thi Thu Loan, Nguyen Duc Tuan. "Development, Validation, and Application for Simultaneous Assay of Metformin and Sitagliptin in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry." Systematic Reviews in Pharmacy 11 (2020), 6-13. doi:10.5530/srp.2020.2.02



MLA (The Modern Language Association) Style

Nguyen Ngoc Nha Thao, Nguyen Ngoc Hieu, Do Chau Minh Vinh Tho, Trinh Thi Thu Loan, Nguyen Duc Tuan. "Development, Validation, and Application for Simultaneous Assay of Metformin and Sitagliptin in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry." Systematic Reviews in Pharmacy 11.2 (2020), 6-13. Print. doi:10.5530/srp.2020.2.02



APA (American Psychological Association) Style

Nguyen Ngoc Nha Thao, Nguyen Ngoc Hieu, Do Chau Minh Vinh Tho, Trinh Thi Thu Loan, Nguyen Duc Tuan (2020) Development, Validation, and Application for Simultaneous Assay of Metformin and Sitagliptin in Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry. Systematic Reviews in Pharmacy, 11 (2), 6-13. doi:10.5530/srp.2020.2.02





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