Simultaneous determination of rivaroxaban and sitagliptin in rat plasma by LC–MS/MS and its application to pharmacokinetic drug-drug interaction study

• Autorzy: Wang Libin , Shang Kun , Zhang Xiaorui , Zhang Xinying , Feng Tian , Xu Xiaohui , Wang Fang

Identyfikatory

DOI

10.1556/1326.2021.00988

• Języki publikacji: EN

Abstrakty

EN

A sensitive and accurate LC-MS/MS method was developed and validated for the simultaneous quantification of rivaroxaban (RIV) and sitagliptin (SIT) in rat plasma using apixaban as internal standard (IS). An Agilent Eclipse plus C18 column (2.1 × 100 mm, 3.5 µm, Agilent) was used for chromatographic separation with isocratic elution. Multiple reaction monitoring (MRM) using positive-ion ESI mode to monitor ion transitions of m/z 436.8→144.9 for RIV, m/z 407.7→173.8 for SIT, m/z 459.8→442.8 for IS. The procedure of method validation included selectivity, linearity, precision, accuracy, matrix effect, extraction recovery and stability were conducted according to the guidelines of EMA and FDA. The results indicated that no obvious drug-drug interactions occurred might be owing to their differences in metabolic pathways.

Słowa kluczowe

EN

LC-MS/MS; rivaroxaban; sitagliptin; drug-drug interaction

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2022
• Tom: Vol. 34, no. 4
• Strony: 430--436
• Opis fizyczny: Bibliogr. 19 poz., tab., rys., wykr.

Twórcy

autor

Wang Libin

• School of Medicine, Shaanxi Energy Institute, Xianyang, Shaanxi Province, 712000, China

autor

Shang Kun

• College of Medicine, Yan'an University, Yan'an, Shaanxi Province, 716000, China

autor

Zhang Xiaorui

• Department of Pharmacy, The PLA 986th Hospital, Xi'an, 710032, China

autor

Zhang Xinying

• School of Medicine, Shaanxi Energy Institute, Xianyang, Shaanxi Province, 712000, China

autor

Feng Tian

• Department of Medicinal Chemistry and Pharmaceutical Analysis, School of Pharmacy, Air Force Military Medical University, Xi'an, 710032, China

autor

Xu Xiaohui

• Department of Orthopaedics, DeZhou People’s Hospital, DeZhou, Shandong Province, 253000, China

• https://orcid.org/0000-0003-2514-4759

autor

Wang Fang

• School of Medicine, Shaanxi Energy Institute, Xianyang, Shaanxi Province, 712000, China

• https://orcid.org/0000-0003-3976-3673

Bibliografia

• 1. Kharroubi, A. T.; Darwish, H. M. Diabetes mellitus: the epidemic of the century. World J. Diabetes 2015, 6(6), 850–67.
• 2. Heit, J. A.; Leibson, C. L.; Ashrani, A. A.; Petterson, T. M.; Bailey, K. R.; Melton, L. J., 3rd. Is diabetes mellitus an independent risk factor for venous thromboembolism?: a population-based case-control study. Arterioscler Thromb. Vasc. Biol. 2009, 29(9), 1399–405.
• 3. Piazza, G.; Goldhaber, S. Z.; Kroll, A.; Goldberg, R. J.; Emery, C.; Spencer, F. A. Venous thromboembolism in patients with diabetes mellitus. Am. J. Med. 2012, 125(7), 709–16.
• 4. Petrauskiene, V.; Falk, M.; Waernbaum, I.; Norberg, M.; Eriksson, J. W. The risk of venous thromboembolism is markedly elevated in patients with diabetes. Diabetologia 2005, 48(5), 1017–21.
• 5. Streiff, M. B.; Agnelli, G.; Connors, J. M.; Crowther, M.; Eichinger, S.; Lopes, R.; McBane, R. D.; Moll, S.; Ansell, J. Guidance for the treatment of deep vein thrombosis and pulmonary embolism. J. Thromb. Thrombolysis 2016, 41(1), 32–67.
• 6. Kundu, A.; Sardar, P.; Chatterjee, S.; Aronow, W. S.; Owan, T.; Ryan, J. J. Minimizing the risk of bleeding with NOACs in the elderly. Drugs & Aging 2016, 33(7), 491–500.
• 7. Perzborn, E.; Roehrig, S.; Straub, A.; Kubitza, D.; Mueck, W.; Laux, V. Rivaroxaban: a new oral factor Xa inhibitor. Arterioscler Thromb. Vasc. Biol. 2010, 30(3), 376–81.
• 8. Mueck, W.; Stampfuss, J.; Kubitza, D.; Becka, M. Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clin. Pharmacokinet. 2014, 53(1), 1–16.
• 9. Kreutz, R. A clinical and pharmacologic assessment of once-daily versus twice-daily dosing for rivaroxaban. J. Thromb. Thrombolysis 2014, 38(2), 137–49.
• 10. Harder, S. Pharmacokinetic and pharmacodynamic evaluation of rivaroxaban: considerations for the treatment of venous thromboembolism. Thromb. J. 2014, 12(1), 22.
• 11. Scott, L. J. Sitagliptin: a review in type 2 diabetes. Drugs 2017, 77(2), 209–24.
• 12. Dhillon, S. Sitagliptin. Drugs 2010, 70(4), 489–512.
• 13. Hanefeld, M.; Herman, G. A.; Wu, M.; Mickel, C.; Sanchez, M.; Stein, P. P. Once-daily sitagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of patients with type 2 diabetes. Curr. Med. Res. Opin. 2007, 23(6), 1329–39.
• 14. Mega, C.; Teixeira-de-Lemos, E.; Fernandes, R.; Reis, F. Renoprotective effects of the dipeptidyl peptidase-4 inhibitor sitagliptin: a review in type 2 diabetes. J. Diabetes Res. 2017, 2017, 5164292.
• 15. Ujihara, N.; Sakura, H.; Hashimoto, N.; Sasamoto, K.; Ohashi, H.; Hasumi, S.; Kasahara, T.; Tomonaga, O.; Nunome, H.; Honda, M.; Iwamoto, Y.; Sato, A.; Miyashita, A.; Kokubo, A.; Tsuchiya, A.; Hirohara, D.; Kogure, D.; Kasahara, D.; Tanaka, H.; Tanaka, H.; Tezuka, H.; Kuroki, H.; Ogino, J.; Kin, K.; Kin, K.; Muto, K.; Suzuki, K.; Iseki, K.; Watanabe, K.; Higami, K.; Matsumura, K.; Nakajima, K.; Shin, K.; Koizumi, K.; Saneshige, M.; Sekine, M.; Yaida, M.; Kiuchi, M.; Mugishima, M.; Osawa, M.; Banno, M.; Yamamoto, M.; Hiratsuka, M.; Hosoya, M.; Atsuta, M.; Kato, M.; Morita, M.; Miyamae, M.; Iijima, M.; Okuyama, N.; Hisano, N.; Tsuchiya, N.; Wada, R.; Wada, R.; Momose, R.; Otake, S.; Maruyama, S.; Takada, S.; Dan, S.; Nishizawa, S.; Yamashita, S.; Saneshige, S.; Teno, S.; Tsuruta, S.; Kumakura, S.; Kijima, S.; Kondo, T.; Onishi, T.; Kudo, T.; Sugiura, T.; Ishiguro, T.; Suzuki, Y.; Tomita, Y.; Takano, Y.; Akimoto, Y.; Odanaka, Y.; Tasaka, Y.; Aiso, Y.; Inoue, Y.; Kobayashi, Y.; for the, J. S. I. Efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus and comparison of hypoglycemic action of concomitant medications: a subanalysis of the JAMP study. Diabetology Int. 2018, 9(1), 56–65.
• 16. Abdallah, M. A.; Al-Ghobashy, M. A.; Lotfy, H. M. Investigation of the profile and kinetics of degradation of rivaroxaban using HPLC, TLC-densitometry and LC/MS/MS: application to pre-formulation studies. Bull. Fac. Pharm. Cairo Univ. 2015, 53(1), 53–61.
• 17. Iqbal, M.; Khalil, N. Y.; Imam, F.; Khalid Anwer, M. A validated high-throughput UHPLC-MS/MS assay for accurate determination of rivaroxaban in plasma sample. J. Thromb. Thrombolysis 2015, 39(1), 79–88.
• 18. Loh, G. O. K.; Wong, E. Y. L.; Tan, Y. T. F.; Lee, Y. L.; Pang, L. H.; Chin, M. C.; Damenthi, N.; Peh, K. K. Simple and rapid LC-MS/MS method for determination of sitagliptin in human plasma and application to bioequivalence study. J. Chromatogr. B 2020, 1159, 122337.
• 19. Zeng, W.; Musson, D. G.; Fisher, A. L.; Chen, L.; Schwartz, M. S.; Woolf, E. J.; Wang, A. Q. Determination of sitagliptin in human urine and hemodialysate using turbulent flow online extraction and tandem mass spectrometry. J. Pharm. Biomed. Anal. 2008, 46(3), 534–42.

Uwagi

Opracowanie rekordu ze środków MEiN, umowa nr SONP/SP/546092/2022 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2022-2023).