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

Abstract

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

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.

Most Viewed Articles
  • Dental Development between Assisted Reproductive Therapy (Art) and Natural Conceived Children: A Comparative Pilot Study Norzaiti Mohd Kenali, Naimah Hasanah Mohd Fathil, Norbasyirah Bohari, Ahmad Faisal Ismail, Roszaman Ramli SRP. 2020; 11(1): 01-06 » doi: 10.5530/srp.2020.1.01
  • Psychometric properties of the World Health Organization Quality of life instrument, short form: Validity in the Vietnamese healthcare context Trung Quang Vo*, Bao Tran Thuy Tran, Ngan Thuy Nguyen, Tram ThiHuyen Nguyen, Thuy Phan Chung Tran SRP. 2020; 11(1): 14-22 » doi: 10.5530/srp.2019.1.3
  • A Review of Pharmacoeconomics: the key to “Healthcare for All” Hasamnis AA, Patil SS, Shaik Imam, Narendiran K SRP. 2019; 10(1): s40-s42 » doi: 10.5530/srp.2019.1s.21
  • Deuterium Depleted Water as an Adjuvant in Treatment of Cancer Anton Syroeshkin, Olga Levitskaya, Elena Uspenskaya, Tatiana Pleteneva, Daria Romaykina, Daria Ermakova SRP. 2019; 10(1): 112-117 » doi: 10.5530/srp.2019.1.19
Most Downloaded
  • Dental Development between Assisted Reproductive Therapy (Art) and Natural Conceived Children: A Comparative Pilot Study Norzaiti Mohd Kenali, Naimah Hasanah Mohd Fathil, Norbasyirah Bohari, Ahmad Faisal Ismail, Roszaman Ramli SRP. 2020; 11(1): 01-06 » doi: 10.5530/srp.2020.1.01
  • Manilkara zapota (L.) Royen Fruit Peel: A Phytochemical and Pharmacological Review Karle Pravin P, Dhawale Shashikant C SRP. 2019; 10(1): 11-14 » doi: 0.5530/srp.2019.1.2
  • Pharmacognostic and Phytopharmacological Overview on Bombax ceiba Pankaj Haribhau Chaudhary, Mukund Ganeshrao Tawar SRP. 2019; 10(1): 20-25 » doi: 10.5530/srp.2019.1.4
  • A Review of Pharmacoeconomics: the key to “Healthcare for All” Hasamnis AA, Patil SS, Shaik Imam, Narendiran K SRP. 2019; 10(1): s40-s42 » doi: 10.5530/srp.2019.1s.21
  • A Prospective Review on Phyto-Pharmacological Aspects of Andrographis paniculata Govindraj Akilandeswari, Arumugam Vijaya Anand, Palanisamy Sampathkumar, Puthamohan Vinayaga Moorthi, Basavaraju Preethi SRP. 2019; 10(1): 15-19 » doi: 10.5530/srp.2019.1.3