Validación de un método para determinar la concentración sérica de voriconazol por HPLC/UV

  1. A. Aguilar Romero 1
  2. J.E. Gómez Sanz 1
  3. P. Granda Lobato 1
  4. H. Gonzalo Salado 2
  5. P. Sánchez López 2
  6. M. Sánchez de Castro 3
  7. A. Zarzuelo Castañeda 4
  8. P. Montenegro Álvarez de Tejera 5
  1. 1 Capitán farmacéutico. Escuela Militar de Sanidad (EMISAN). Academia Central de la Defensa.
  2. 2 Teniente coronel farmacéutica. Hospital Central de la Defensa Gómez Ulla. Servicio de Farmacia Hospitalaria.
  3. 3 Farmacéutico adjunto. Hospital Central de la Defensa Gómez Ulla. Servicio de Farmacia Hospitalaria.
  4. 4 Área de farmacia y tecnología farmacéutica. Departamento Ciencias Farmacéuticas. Facultad de Farmacia, Salamanca.
  5. 5 Dra. Ciencias Biológicas. Hospital Central de la Defensa Gómez Ulla. Servicio de Farmacia Hospitalaria.
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Journal:
Sanidad militar: revista de sanidad de las Fuerzas Armadas de España

ISSN: 1887-8571

Year of publication: 2022

Issue Title: Julio - Septiembre 2022

Volume: 78

Issue: 3

Pages: 146-150

Type: Article

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More publications in: Sanidad militar: revista de sanidad de las Fuerzas Armadas de España

Abstract

Background. The high increase of invasive fungal infections has increased the use of voriconazole as prophylaxis and treatment, being necessary to monitor its serum concentrations. Objective.To standardize and validate a simple method with high efficacy and specificity for the determination of voriconazole. Method. For the quantification of voriconazole, a Shimadzu high performance liquid chromatography equipment was used, coupled to an ultraviolet-visible diode array detector, performing the chromatographic separation with a Brisa LC2 C18 column. The chromatographic conditions defined were: column temperature, 35ºC; wavelength, 256 nm; injection volume, 20 µl; flow rate, 1.5 ml/min; analysis time, 9 min, mobile phase water with formic acid 0.5 % / acetonitrile 65/35. Prior to chromatographic injection, the samples underwent a treatment consisting of protein precipitation with acetonitrile and subsequent centrifugation, and the supernatant was injected The SPSS v. 25 statistical program was used, considering a p<0.05 as statistically significant. Results. The method developed is selective and linear (r2 =1), with a coefficient of variation ≤ 5%. In terms of accuracy and precision, the coefficients of variation were ≤ 5 %, thus complying with the requirements established for the concentration range 0.1 µg/ml-10 µg/ml. Conclusion. The selectivity and the simplicity of the sample treatment make it an effective, fast and simple method for the determination of voriconazole in serum and with a higher sensitivity than the immunoassays used.

Bibliographic References

  • 1. Ficha técnica voriconazol Sandoz 200mg polvo para solución para perfusión EFG. https://cima.aemps.es/cima/dochtml/ft/79141/FichaTecnica_79
  • 2. Abdul-Aziz MH, Alffenaar JC, Bassetti M, et al. Antimicrobial therapeutic drug monitoring in critically ill adult patients: a Position Paper. Intensive Care Med. 2020; 46(6):1127-1153. https://link.springer.com/article/10.1007% 2Fs00134-020-06050-1
  • 3. Shi C, Xiao Y, Mao Y, Wu J, Lin N. Voriconazole: A Review of Population Pharmacokinetic Analyses. Clin Pharmacokinet. 2019; 58(6):687-703.
  • 4. Trifilio S, Kamal K, Pennick G, Pi J, Golf M, Mehta Y. Discordance between voriconazole dose and plasma concentrations. Biol Blood Marrow Transplant, 2007; 13(2):154-154
  • 5. Rodriguez A, Reyes J, Castaño Gamboa N. Assessment of the efficacy and safety of voriconazole, compared with avaliable therapies in the treatment of patients with invaisive aspergillosis: a netword meta-analysis.Valuein Health. 2018; 21:S240. https://www.valueinhealthjournal.com/action/ showPdf?pii=S1098-3015%2818%2934734-X
  • 6. Leslie Escobar QF. Monitorizacion terapéutica de fármacos y aspectos prácticos de farmacocinética. Rev Med Clin Condes. 2016; 27(5):605-6014. https://doi.org/10.1016/j.rmclc.2016.09.006
  • 7. Zheng YZ, Wang S. Advances in antifungal drug measurement by liquid chromatography-mass spectrometry. Clin Chim Acta. 2019; 491:132-145. https://pubmed.ncbi.nlm.nih.gov/30685359/
  • 8. Gage R, Stopher DA. A rapid HPLC assay for voriconazole in human plasma. J Pharm Biomed Anal. 1998; 17(8):1449-1453.
  • 9. ICH Harmonised Tripartite Guidline. Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonisation of Tecnichal Requirements for Registration of Pharmaceutical Humans Use. Geneve. 2005. https://www.ema.europa.eu/en/documents/scientific-guideline/ ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf
  • 10. Chhun S, Rey E, Tran A, Lortholary O, Pons G, Jullien V. Simultaneous quantification of voriconazole and posaconazole in human plasma by highperformance liquid chromatography with ultra-violet detection. J Chromatogr B Analyt Technol Biomed Life Sci. 2007; 852(1-2):223-228.
  • 11. Zhang M, Moore GA, Barclay ML, Begg EJ. A simple high-performance liquid chromatography method for simultaneous determination of three triazole antifungals in human plasma. Antimicrob Agents Chemother. 2013; 57(1):484-489. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3535916
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