Validation of spectrophotometric analytical method to quantify glibenclamide in 5 mg tablets;Validación de un método analítico espectrofotométrico para cuantificar glibenclamida en tabletas de 5 mg

Revista Mexicana de Ciencias Farmaceuticas

Volumn 36, Issue 3, 2005, Pages 33-41

  López Marzo, Adaris M ^a,c   Felizola Ch, Alexander ^b   Hernández C, Víctor O ^b   Cuartero C, Thomas M ^b  

^a NATL CENTER FOR SCIENTIFIC RESEARCH   (Cuba)

^b Laboratorios MedSol   (Cuba)

^c Centro de Investigaciones del Ozono   (Cuba)

Author keywords

Glibenclamide tablets; Spectrophotometric method; Validation

Indexed keywords

ALCOHOL; CARBAMIC ACID DERIVATIVE; EXCIPIENT; GLIBENCLAMIDE; PLACEBO; SOLVENT; SULFONAMIDE;

ACCURACY; ANALYTIC METHOD; ARTICLE; CALCULATION; CALIBRATION; CORRELATION COEFFICIENT; QUALITY CONTROL; REPRODUCIBILITY; SPECTROPHOTOMETRY; TABLET; VALIDATION PROCESS;

EID: 23844473747     PISSN: 10273956     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (14)

1. Martindale, The Extra Pharmacopeia. 1993. Reynolds F. J. E. (ed). 30a. ed The Pharmaceuticals Press, London, p. 279.
2. Formulario Nacional de Medicamentos. Febrero del 2003. Cheping S. N., Diaz A. M. (eds). Editorial Ciencias Médicas, Cuba, pp. 413-414.
3. Davis S.N., Granner D.K., 1996. Insulin, oral hypoglycemic agents, and the pharmacology of the endocrine pancreas. En: Goodman & Gilman The pharmacological bases of therapeutics. Hardman J.G., Limbird L. E., Molinoff P. B., Ruddon R.W., Goodman G. A. (eds) 19a ed. McGraw-HILL International edition, pp. 1487-1500.
4. Arky R. 1994. Physicians' Desk Reference. 48 ed. Medical Economic Company Inc., p. 1040.
5. Monographs, Glibenclamide tablets. 1998. En: British Pharmacopoeia. The Stationary Office Limited, United Kingdom, vol. 2, p. 433.
6. Monographs, Glibenclamide tablets. 2000. En: British Pharmacopoeia. The Stationary Office Limited, United Kingdom, vol. 2, p. 468.
7. Official Monographs: Glyburide y General information: Validation of Compendials Methods. 2000. En: United States Pharmacopoeia 24 and National Formulary 19. United States Pharmacopeial Convention, Inc., Rockville, MD, vol. 2, pp. 779-780 y pp. 2149-2152.
8. Official Monographs: Glyburide. 2002. United States Pharmacopoeia 25 and National Formulary 20. United States Pharmacopeial Convention Inc., Rockville, MD, vol. 2, pp. 806-807.
9. Castro M, Gascón S., Pujol M., Sans J. P., Vicente L. L. 1989. Validación de métodos analíticos. En: Monografía de la Asociación Española de Farmacéuticos de la Industria. Edición Hewlett Packard, pp. 1-94.
10. Camacho M. A., Torres A. I., Gil M. E., Obregón M. M., Ruz V. 1993. Validation of analytical methods for finished pharmaceutical products. STP Pharma Practiques, 3(3): 197-202.
11. Harmonised tripartite guideline: text on validation of analytical procedures. En: International conference on harmonization of technical requirements for registration of pharmaceuticals for human Use. 1996. U. S. Departament of Health and Human Services, Federal Register, 60 (40): 11260-11265.
12. Calpena C. A. C. 1990. Validación de los métodos analíticos. Farmacia Clínica, 7(9):749-758.
13. Validación de los métodos analíticos. 1994. En: Farmacopea de los Estados Unidos Mexicanos. Secretaría de Salud México, D. F., pp. 1-73.
14. Moffat A. C. 1986. Clarke's isolation and identification of drugs, in pharmaceuticals, body fluids and post-mortem material. 2a ed. The Pharmaceuticals Press, London, p. 638.