Suárez PY; Rosales GES; González HM; Álvarez IA; Castiñeira DM

Language: Spanish
References: 9
Page: 190-204
PDF size: 160.78 Kb.

ABSTRACT

The undecylenic acid (Micocilen) is a drug in powder presentation containing two active pharmaceutical ingredients: undecylenic acid and zinc undecylenate. By its fungistatic action becames a first line product in Cuba because of mycoses are typical of wet and warm climates. Development and validation of two analytical methods for the quality control on the base of the quantification of each symbol present in the formula. Volumetric techniques were selected by aqueous neutralization and complexometric. Results were satisfactory since in both cases an appropriate specificity, linearity, accuracy, precision and robustness were obtained. Methods proposed were compared to those previously applied obtaining more reliable results, according to results of analytical analysis applied, without significant differences among replica of a same batch.

REFERENCES

1. Mediavilla A, Flórez J. Enfermedades infecciosas. Fármacos antifúngicos. En: Flórez J. Farmacología humana. 3ra ed. Barcelona: Masson, SA; 1997. p. 1173.

2. Ministerio de Salud Pública/Centro para el Desarrollo de la Farmacoepidemiología. Formulario Nacional de Medicamentos. La Habana: Editorial de Ciencias Médicas; 2006. p. 302.

3. Empresa Andrés Berro. Especificaciones de calidad. Micocilén polvo. Procedimiento Normalizado de Operación. L1-419E. La Habana: Empresa Andrés Berro; 2004.

4. Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED). Regulación 37- 2004. Buenas Prácticas de Laboratorio para el Control de Medicamentos. La Habana: CECMED; 2004. p. 17.

5. 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.

6. Centro para el Control Estatal de la Calidad de los Medicamentos (CECMED). Regulación 41-2007. Validación de métodos analíticos. La Habana: CECMED; 2007. p. 6-7.

7. British Pharmacopoeia. Volume I & II Monographs: Medicinal and Pharmaceutical. Versión electrónica. London: The Stationery Office; 2009.

8. United States Pharmacopoeia XXX and National Formulary 25st: United States Pharmacopeial Convention. USP 30. Versión electrónica New York: Pharm Convention Inc.; 2007.

9. Fernández A. Validación de técnicas analíticas. La Habana: Centro de Investigación y Desarrollo de Medicamentos; 1995.