Simultaneous monitoring of ceftaroline fosamil and its active form ceftaroline during stability study of commercial sample - a new stability-indicating HPLC method, drug decomposition in clinical use conditions and degradation products by LC-MS

References

• Biek, D.; Critchley, I. A.; Riccobene, T. A.; Thye, D. A. Ceftaroline Fosamil: A Novel Broad-Spectrum Cephalosporin with Expanded Anti-gram-Positive Activity. J. Antimicrob. Chemoter. 2010, 65, iv9–iv16. DOI: 10.1093/jac/dkq251.
   PubMed Web of Science ®Google Scholar
• Drusano, G. L. Pharmacodynamics of Ceftaroline Fosamil for Complicated Skin and Skin Structure Infection: Rationale for Improved Anti-methicillin-Resistant Staphylococcus aureus Activity. J. Antimicrob. Chemoter. 2010, 65, iv33–iv39. DOI: 10.1093/jac/dkq253.
   PubMed Web of Science ®Google Scholar
• Kaushik, D.; Rathi, S.; Jain, A. Ceftaroline: A Comprehensive Update. Int. J. Antimicrob. Agents 2011, 37, 389–395. DOI: 10.1016/j.ijantimicag.2011.01.017.
   PubMed Web of Science ®Google Scholar
• Laudano, J. B. Ceftaroline Fosamil: A New Broad-Spectrum Cephalosporin. J. Antimicrob. Chemoter. 2011, 66, iii11–iii18. DOI: 10.1093/jac/dkr095.
   PubMed Web of Science ®Google Scholar
• Barsky, E. E.; Pereira, L. M.; Sullivan, K. J.; Wong, A.; Mcadam, A. J.; Sawicki, G. S.; Priebe, G. P.; Goobie, S. M. Ceftaroline Pharmacokinetics and Pharmacodynamics in Patients with Cystic Fibrosis. J. Cyst. Fibros. 2018, 17, e25–e31. DOI: 10.1016/j.jcf.2017.10.010.
   PubMedGoogle Scholar
• Riccobene, T. A.; Carrothers, T. J.; Knebel, W.; Raber, W. S.; Chan, P. L. S. Pharmacokinetic and Pharmacodynamic Target Attainmet in Adult and Pediatric Patients Following Administration of Ceftaroline Fosamil as 5-Minute Infusion. Clin. Pharmacol. Drug Dev. 2021, 10, 420–427. DOI: 10.1002/cpdd.907.
   PubMed Web of Science ®Google Scholar
• Alarcia-Lacalle, A.; Barrasa, H.; Maynar, J.; Canut-Blasco, A.; Gómez-Gonzáles, C.; Solinís, M. A.; Isla, A.; Rodríguez-Gascón, A. Quantification of Ceftaroline Fosamil in Human Plasma Using High-Performance Liquid Chromatography with Ultraviolet Detection: Application to Pharmacokinetic Studies. Pharmaceutics 2021, 13, 959. DOI: 10.3390/pharmaceutics13070959.
   PubMed Web of Science ®Google Scholar
• Grégoire, M.; Leroy, A. G.; Bouquié, R.; Malandain, D.; Dailly, E.; Boutoille, D.; Renaud, C.; Jolliet, P.; Caillon, J.; Deslandes, G. Simultaneous Determination of Ceftaroline, Daptomycin, Linezolid and Rifampicin Concentrations in Human Plasma by on-Line Solid Phase Extraction Coupled to High-Performance Liquid Chromatography-Tandem Mass Spectrometry. J. Pharm. Biomed. Anal. 2016, 118, 17–26. DOI: 10.1016/j.jpba.2015.10.008.
   PubMed Web of Science ®Google Scholar
• Ali, F.; Singh, G.; Sahu, P. L.; Kumar, R.; Trivedi, M. M. Development and Validation of Analytical Method for the Estimation of Ceftaroline Fosamil in Bulk and Pharmaceutical Dosage Form by RP-HPLC. World J. Pharm. Pharm. Sci. 2015, 4, 929–938.
   Google Scholar
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Validation of analytical procedures: Text and methodology Q2(R1). https://ich.org/page/quality-guidelines (accessed Dec 14, 2022).
   Google Scholar
• Mascarello Junior, I. J.; Sponchiado, R. M.; Cordenonsi, L. M.; Oppe, T. O.; Shapoval, E. E. S. Ceftaroline Fosamil: Development a Rapid HPLC Method Indicating Stability and Bioassay for Determination in Pharmaceutical Formulation, Stability and Cytotoxicity Studies. Drug Anal. Res 2021, 5, 36–44. DOI: 10.22456/2527-2616.120343.
   Google Scholar
• KarpiuK, I.; Katarzyna, M.; Katarzyna, B.; Kiljan, M.; Tyski, S. Identification and Determination of Related Substances of Ceftaroline Fosamil in Medicinal Product by High Performance Liquid Chromatography with Diode Array Detection and Tandem Mass Spectrometry. J. Pharm. Biomed. Anal. 2017, 145, 651–660. DOI: 10.1016/j.jpba.2017.07.060.
   PubMed Web of Science ®Google Scholar
• Al Madfai, F.; Zaidi, S. T. R.; Ming, L. C.; Wanandy, T.; Patel, R. P. Physical and Chemical Stability of Ceftaroline in an Elastomeric Infusion Device. Eur. J. Hosp. Pharm. 2018, 25, e115–e119. DOI: 10.1136/ejhpharm-2017-001221.
   PubMedGoogle Scholar
• Bhattacharya, S.; Parekh, S.; Dedhiya, M. In-Use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG plus Containers. Int. J. Pharm. Compound 2015, 19, 432–436.
   PubMedGoogle Scholar
• Ikeda, Y.; Ban, J.; Ishikawa, T.; Hashiguchi, S.; Urayama, S.; Horibe, H. Stability and Stabilization Studies of TAK-599 (Ceftaroline Fosamil), a Novel N-Phosphono Type Prodrug of anti-Methicillin Resistant Staphylococcus aureus Cephalosporin T-91825. Chem. Pharm. Bull. (Tokyo) 2008, 56, 1406–1411. DOI: 10.1248/cpb.56.1406.
   PubMed Web of Science ®Google Scholar
• Okerman, L.; Hende, J. V.; Zutter, L. D. Stability of Frozen Stock Solutions of Beta-Lactam Antibiotics, Cephalosporins, Tetracyclines and Quinolones Used in Antibiotic Residue Screening and Antibiotic Susceptibility Testing. Anal. Chim. Acta 2007, 586, 284–288. DOI: 10.1016/j.aca.2006.10.034.
   PubMed Web of Science ®Google Scholar
• Mendez, A.; Chagastelles, P.; Palma, E.; Nardi, N.; Schapoval, E. Thermal and Alkaline Stability of Meropenem: Degradation Products and Cytotoxicity. Int. J. Pharm. 2008, 350, 95–102. DOI: 10.1016/j.ijpharm.2007.08.023.
   PubMed Web of Science ®Google Scholar
• Barbosa, F. S.; Pezzi, L. C.; Paula, F. R.; Eller, S.; Schapoval, E. E. S.; Oliveira, T. F.; Mendez, A. S. L. Stability Study of Doripenem Antibiotic Applying LC-ESI-Q-TOF Method and in Silico Prediction: An Analytical Investigation Focused on Degradation Products. Microchem. J. 2021, 166, 106230. DOI: 10.1016/j.microc.2021.106230.
   Web of Science ®Google Scholar
• Barbosa, F. S.; Pezzi, L. C.; Tsao, M.; Oliveira, T. F.; Macedo, S. M. D.; Schapoval, E. E. S.; Mendez, A. S. L. Stability and Degradation Products of Imipenem Applying High‐Resolution Mass Spectrometry: An Analytical Study Focused on Solutions for Infusion. Biomed. Chromatogr. 2019, 33, e4471. DOI: 10.1002/bmc.4471.
   PubMed Web of Science ®Google Scholar