Development and validation of a new analytical method based on UV-visible spectroscopy for quantification of ceftaroline fosamil in powder for injection

Lilian F. Machioli; Gabriele C. Rosa; Graciela Carlos; Andreas Sebastian Loureiro Mendez

doi:10.22456/2527-2616.133273

Authors

Lilian F. Machioli College of Pharmacy, Federal University of Rio Grande do Sul https://orcid.org/0009-0008-7433-6355
Gabriele C. Rosa College of Pharmacy, Federal University of Rio Grande do Sul https://orcid.org/0009-0006-3841-266X
Graciela Carlos Postgraduate Program in Pharmaceutical Sciences, Federal University of Rio Grande do Sul https://orcid.org/0000-0001-5626-3780
Andreas Sebastian Loureiro Mendez Postgraduate Program in Pharmaceutical Sciences, Federal University of Rio Grande do Sul https://orcid.org/0000-0001-7991-7521

DOI:

https://doi.org/10.22456/2527-2616.133273

Keywords:

ceftaroline fosamil, UV spectrophotometry, validation, quality control

Abstract

Quantification of drugs is an essential part for ensuring quality, safety and efficacy of pharmaceutical formulations. For this, validated methods must be used in order to guarantee analytical reliability during monitoring in clinical studies and quality control. In the present study, we aim to develop a reliable, accurate, accessible and rapid UV-VIS spectrophotometry method for quantification of ceftaroline fosamil in powder for intravenous administration. Each analyzed solution was prepared individually and the only reagent used was Milli-Q water, as a solvent, making the method eco-friendly. The absorbances were measured at 242 nm, the peak absorbance found for the drug. The developed method was validated according to ICH and ANVISA guidelines, proving to be specific and demonstrating good linearity in the concentration range of 5 μg.mL^-1 to 15 μg.mL^-1, with determination (r²) and correlation coefficients (r) equal to 0.9999. The limits of detection and quantification found were acceptable (0.51 μg.mL^-1 and 1.55 μg.mL^-1, respectively). The method exhibited excellent intermediate precision and repeatability, with relative standard deviation values of 0.87% and 0.98%, respectively. Furthermore, the method’s accuracy was confirmed, showing a mean recovery of 100 ± 2.67%. Additionally, the robustness was assayed and confirmed using Plackett-Burmann design. In conclusion, the method can easily be applied for routine quality control analysis.

Downloads

Download data is not yet available.

References

Lowes R. FDA Approves New Antibiotic for Pneumonia, Skin Infections [Internet]. Medscape. 2010 [cited 2023 May 1]. Available from: https://www.medscape.com/viewarticle/731666

ANVISA aprova Zinforo (ceftarolina fosamila) para infecções complicadas de pele e tecidos moles e pneumonia adquirida na comunidade. www.sboc.org.br. Sociedade Brasileira de Oncologia Clínica; 2014 [cited 2023 Jun 1]. Available from: https://www.sboc.org.br/noticias/item/485-anvisaaprova-zinforo-ceftarolina-fosamila-para-infeccoescomplicadas-de-pele-e-tecidos-moles-e-pneumoniaadquirida-na-comunidade

Ghamrawi RJ, Neuner E, Rehm SJ. Ceftaroline fosamil: A super-cephalosporin? Cleveland Clinic Journal of Medicine. 2015 Jul;82(7):437–44.

Shirley DAT, Heil EL, Johnson JK. Ceftaroline Fosamil: A Brief Clinical Review. Infectious Diseases and Therapy. 2013 Aug 8;2(2):95–110.

Moretto P, Carlos G, Barbosa FS, Garcia CV, de Oliveira TF, Mendez ASL. 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. Journal of Liquid Chromatography & Related Technologies [Internet]. 2023;1–11. Available from: https://doi.org/10.1080/10826076.2023.2216750.

Jabeen J, Bangalore Venkatappa Suma. Newly validated stability-indicating ultra-performance liquid chromatography-tandem mass spectrometry method for the estimation of Ceftaroline Fosamil by using a quadrupole mass detector. Journal of Applied Pharmaceutical Science. 2022 Jun 5;12(6):215–23.

Helfer VE, Dias BB, Lock G de A, Tomaszewski CA, Barnet LS, Barreto F, et al. Development and validation of an LC-MS/MS method to quantify ceftaroline in microdialysate samples from plasma and brain: Application to a preclinical pharmacokinetic investigation. Heliyon. 2023 May 1;9(6):e16564–4.

Grégoire M, Leroy AK, Bouquié R, Malandain D, Dailly E, Boutoille D, et al. Simultaneous determination of ceftaroline, daptomycin, linezolid and rifampicin concentrations in human plasma by online solid phase extraction coupled to highperformance liquid chromatography–tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis. 2016 Jan 25;118:17–26.

Alarcia-Lacalle A, Barrasa H, Maynar J, Canut-Blasco A, Gómez-González C, Solinís MÁ, et al. Quantification of Ceftaroline in Human Plasma Using High-Performance Liquid Chromatography with Ultraviolet Detection: Application to Pharmacokinetic Studies. Pharmaceutics. 2021 Jun 25;13(7):959.

Reddy PG, Kumar VK, Raju VVSSA, Ram JR, Raju NA. The Estimation of Ceftaroline Fosamil in Lyophillized Powder for Injection by RP-HPLC. Research Journal of Pharmacy and Technology. 2018;11(2):455.

Mascarello Junior IJ, Sponchiado RM, Cordenonsi LM, Oppe TO, Shapoval EES. Ceftaroline fosamil: development a rapid HPLC method indicating stability and bioassay for determination in pharmaceutical formulation, stability and cytotoxicity studies. Drug Analytical Research. 2021 Dec 15;5(2):36–44.

Atomic Absorption Spectroscopy. In: Vogel’s textbook of quantitative chemical analysis. Harlow: Prentice Hall; 2000.

Hammond JP. The Use of Spectrophotometry in the Pharmaceutical Industry. In: Experimental Methods in the Physical Sciences. Academic Press; 2014. p. 409– 56.

International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceutical for Human Use. Validation of analytical procedures: text and methodology Q2(R1). Geneva; 2005.

Agência Nacional de Vigilância Sanitária (ANVISA). Resolução RDC n° 166 de 27 de julho de 2017. Dispõe sobre a validação de métodos analíticos e dá outras providências. Brasília, DF: Diário Oficial da União; 2017. Portuguese.

Mašković M, Jančić-Stojanović B, Malenović A, Ivanović D, Medenica M. Assessment of liquid chromatographic method robustness by use of Plackett-Burman design. Acta Chromatographica. 2010 Jun;22(2):281–96.