Ingredient Analysis

Determination of meropenem and vaborbactam for injection by high performance liquid chromatography*

  • WANG Jing ,
  • XU Shuo ,
  • WANG Yue ,
  • GUO Si-rui ,
  • XU Wen-feng ,
  • JIN Peng-fei
Expand
  • Department of Pharmacy, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application, Beijing 100730, China

Received date: 2024-03-15

  Online published: 2025-01-07

Abstract

Objective: To develop a method for the determination of meropenem and vaborbactam for injection by HPLC. Methods: The chromatography was performed on Shimadzu InertSustain C18(150 mm×4.6 mm, 5 μm)column with acetonitrile-0.02 mol·L-1 sodium dihydrogen phosphate solution (adjust pH to 2.8 with phosphoric acid)(10∶90) as a mobile phase, the flow rate was 1.0 mL·min-1, the detection wavelength was 210 nm, and the sample volume was 10 μL. A method for the determination of meropenem and vaborbactam for injection was established under the chromatographic conditions. Results: In this method, the linearities of meropenem and vaborbactam were good, and the linearity ranges were 21.40-214.0 μg·mL-1 and 19.83-198.3 μg·mL-1. Meropenem and vaborbactam had good precision with RSD of 0.31% and 0.16%, respectively. Within 24 h, meropenem and vaborbactam had good stabilities at 4 ℃, RSDs were 0.31% and 0.16%, respectively. The average recoveries of meropenem and vaborbactam were 101.0%(n=9) and 98.4%(n=9) (RSD<2.0%). The contents of meropenem and vaborbactam were 405.8 mg·g-1 and 399.1 mg·g-1, respectively. Conclusion: The method is accurate, simple and rapid, and can be used for the determination of meropenem and vaborbactam for injection.

Cite this article

WANG Jing , XU Shuo , WANG Yue , GUO Si-rui , XU Wen-feng , JIN Peng-fei . Determination of meropenem and vaborbactam for injection by high performance liquid chromatography*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44(10) : 1679 -1684 . DOI: 10.16155/j.0254-1793.2024-0175

References

[1] MENNINI FS, GORI M, VLACHAKI I, et al. Cost-effectiveness analysis of vaborem in carbapenem-resistant enterobacterales(CRE)-Klebsiella pneumoniae infections in Italy[J]. Health Econ Rev, 2021, 11(1):42
[2] VLACHAKI I, ZINZI D, FALLA E, et al. Cost-effectiveness analysis of vaborem for the treatment of carbapenem-resistant Enterobacteriaceae-Klebsiella pneumoniae carbapenemase (CRE-KPC) infections in the UK[J]. Eur J Health Econ, 2022, 23(3):537
[3] TAGGAR G, ATTIQ RM, BOERLIN P, et al. Molecular epidemiology of carbapenemases in enterobacteriales from humans, animals, food and the environment[J]. Antibiotics (Basel), 2020, 9(10):693
[4] GAIBANI P, GIANI T, BOVO F, et al. Resistance to ceftazidime/avibactam, meropenem/vaborbactam and imipenem/relebactam in gram-negative MDR bacilli: molecular mechanisms and susceptibility testing[J]. Antibiotics (Basel), 2022, 11(5):628
[5] DAVID S, REUTER S, HARRIS SR, et al. Epidemic of carbapenem-resistant Klebsiella pneumoniae in Europe is driven by nosocomial spread[J]. Nat Microbiol, 2019, 4(11):1919
[6] BOUZA E. The role of new carbapenem combinations in the treatment of multidrug-resistant Gram-negative infections[J]. J Antimicrob Chemother, 2021, 76(4):iv38
[7] BHOWMICK T, WEINSTEIN MP. Microbiology of meropenem-vaborbactam: a novel carbapenem beta-lactamase inhibitor combination for carbapenem-resistant Enterobacterales infections[J]. Infect Dis Ther, 2020, 9(4):757
[8] SHORTRIDGE D, KANTRO V, CASTANHEIRA M. Meropenem-vaborbactam activity against U.S. multidrug-resistant enterobacterales strains, including carbapenem-resistant isolates[J]. Microbiol Spectr, 2023, 11(1):1
[9] CASTANHEIRA M, DOYLE TB, DESHPANDE LM, et al. Activity of ceftazidime/avibactam, meropenem/vaborbactam and imipenem/relebactam against carbapenemase-negative carbapenem-resistant Enterobacterales isolates from US hospitals[J]. Int J Antimicrob Agents, 2021, 58(5):106439
[10] WUNDERINK RG, GIAMARELLOS-BOURBOULIS EJ, RAHAV G, et al. Effect and safety of meropenem-vaborbactam versus best-available therapy in patients with carbapenemresistant Enterobacteriaceae infections: the TANGO Ⅱ randomized clinical trial [J]. Infect Dis Ther, 2018, 7(4):439
[11] RUBINO CM, BHAVNANI SM, LOUTIT JS, et al. Phase 1 study of the safety, tolerability, and pharmacokinetics of vaborbactam and meropenem alone and in combination following single and multiple doses in healthy adult subjects[J]. Antimicrob Agents Chemother, 2018, 62(4):e02228
[12] RUBINO CM, BHAVNANI SM, LOUTIT JS, et al. Single-dose pharmacokinetics and safety of meropenem-vaborbactam in subjects with chronic renal impairment[J]. Antimicrob Agents Chemother, 2018, 62(3):e02103
[13] DOI Y. Treatment options for carbapenem-resistant gram-negative bacterial infections[J]. Clin Infect Dis, 2019, 69(Supp l7):S565
[14] SUTHERLAND CA, NICOLAU DP. Development of an HPLC method for the determination of meropenem/vaborbactam in biological and aqueous matrixes[J]. J Chromatogr Sci, 2020, 58(8):726
[15] BARONE R, CONTI M, GIORGI B, et al. Fast and sensitive method for simultaneous quantification of meropenem and vaborbactam in human plasma microsamples by liquid chromatography-tandem mass spectrometry for therapeutic drug monitoring[J]. Antibiotics(Basel), 2023, 12(4):719
Outlines

/