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.
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
[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