González FLS, Samé PAM

Language: Spanish
References: 7
Page: 446-454
PDF size: 75.04 Kb.

ABSTRACT

Introduction: Furvinol is a Cuban ophthalmic ointment for veterinary purposes. It is used in the external treatment of ocular infections in animals due to its wide spectrum antibacterial action. Its active principle derived from the sugar cane known as Furvina or G-1.
Objective: to develop a method based on UV Vis spectrophotometry for application in quality control of Furvinol.
Methods: a quick procedure prior to analysis was established, which consisted of extraction of G-1 from the ointment base by using n-hexane and dimethylsulfoxide as solvents, with a high percentage of recovery. Subsequently, the concentration of G-1 solution in dimethylsulfoxide (0,012 mg/mL) at 386 nm highest absorption wavelength was determined. The prospective validation was applied according to the present regulatory demands.
Results: it was proved that the method was linear, precise, accurate and robust in the studied range.
Conclusions: the results assure the reliability of the method for quantification of G-1 during the quality control.

REFERENCES

1. Fabbretti A, Brandi L, Petrelli D, Pon CL, Castañedo NR, Medina R, et al. The antibiotic Furvina® targets the P-site of 30S ribosomal subunits and inhibits translation initiation displaying start codon bias. Nucleic Acids Research, 2012:40(20), 10366-74.

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3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Validation of analytical procedures: text and methodology. Q2 (R1). Washington: Food and Drug Administration; 2005. p. 1-2.

4. Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED). Regulación 41-2007. Validación de métodos analíticos. La Habana: CECMED; 2007.

5. British Pharmacopoeia. Validation of analytical procedures. London: The Stationery Office; 2011.

6. United States Pharmacopoeial Convention XXXIII and National Formulary 28st. USP XXXIII. United States Pharmacopoeia Convention. 33 ed. Rockville: Mack Printing; 2010.

7. Fernández A. Validación de técnicas analíticas. La Habana: Centro de Investigación y Desarrollo de Medicamentos; 1995. p. 1- 27, 33 -35.