Validation of analytical methods for the quality control of Naproxen suppositories

Yaslenis Rodríguez Hernández; Yania Suárez Pérez; Oscar García Pulpeiro; Orestes Yuniel Hernández Contreras

2011, Number 3

<< Back Next >>

Rev Cubana Farm 2011; 45 (3)

Validation of analytical methods for the quality control of Naproxen suppositories

Rodríguez HY, Suárez PY, García PO, Hernández COY

Full text

How to cite this article

Language: Spanish
References: 9
Page: 341-354
PDF size: 192.64 Kb.

ABSTRACT

The analysis methods that will be used for the quality control of the future Cubanmade Naproxen suppositories for adults and children were developed for the first time in this paper. One method based on direct ultraviolet spectrophotometry was put forward, which proved to be specific, linear, accurate and precise for the quality control of Naproxen suppositories, taking into account the presence of chromophore groups in their structure. Likewise, the direct semi-aqueous acid-base volumetry method aimed at the quality control of the Naproxen raw material was changed and adapted to the quality control of suppositories. On the basis of the validation process, there was demonstrated the adequate specificity of this method with respect to the formulation components, as well as its linearity, accuracy and precision in 1-3 mg/mL range. The final results were compared and no significant statistical differences among the replicas per each dose were found in both methods; therefore, both may be used in the quality control of Naproxen suppositories.

REFERENCES

Insel PA. Analgésicos-antipiréticos, antiinflamatorios y fármacos antigotosos. En: Goodman LS & Gilman A. Las bases farmacológicas de la terapéutica. 9na ed. Vol. I, Cap. 27. Monterrey: Healtcare Group; 2002. p. 661-705.
Feria M. Fármacos analgésicos, antitérmicos y antiinflamatorios no esteroideos. Antiartríticos. En: Florez J. Farmacología humana. 4ta ed. Cap. 22. Barcelona: Editorial: Masson; 2005. p. 393-4.
Ansel HC, Popovich NG, Allen LV. Pharmaceutical Dosage Forms and Drug Delivery Systems. 6ta ed. Baltimore: Lippincott Williams & Wilkins; 1999. p. 101-6.
Mora CP, Tello ME, Martínez F. Validación de una metodología analítica para la cuantificación de naproxeno en estudios de reparto líquido/líquido mediante espectrofotometría ultravioleta. Re Col Cienc. Quím Farm. 2006;35:81-105.
United States Pharmacopoeial Convention XXX and National Formulary 25st. USP XXX. United States Pharmacopoeia Convention. 30 ed. Rockville: Mack Printing; 2007. Versión electrónica.
PLM. Diccionario de Especialidades Farmacéuticas. 36ta ed. Bogotá: Thomson Healthcare; 2008. Versión electrónica.
Clínica Universidad de Navarra. Antiinflamatorios no esteroideos vía sistémica. naproxeno, 2009. Disponible en: http://www.cun.es/
British Pharmacopoeia. Volume I & II Monographs: Medicinal and Pharmaceutical Substances Naproxen. London: The Stationary Office; 2009. Versión electrónica.
Ministerio de Salud Pública. Centro para el Desarrollo de la Farmacoepidemiología. Formulario Nacional de Medicamentos. Cap. 2. La Habana: Editorial Ciencias Médicas; 2006. p. 30, 33.