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2011, Number 2

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Rev Cubana Farm 2011; 45 (2)

Stability of a1 mg/mL oral solution zidovudine

García PCM; Morales LI; Martínez EV
Full text How to cite this article

Language: Spanish
References: 7
Page: 226-236
PDF size: 117.68 Kb.


Key words:

Zidovudine, validation, stability studies.

ABSTRACT

The carrying out of a high-performance liquid chromatography analytical method was assessed; applicable to stability study of oral solution zidovudine (1 mg/mL) was made. The analytical method was linear, precise, specific and exact in the study concentrations. The stability study of oral solution zidovudine (1 mg/mL) was conducted determining expiring date. The shelf life study was conducted over 24 months at room temperature; whereas that of accelerated stability was conducted with the product under wet and temperature conditions; analysis was carried out over three months. Formula met quality specifications described in Pharmacopeia. Results from the shelf life study demonstrated that product keeps the parameters determining its quality during that time and in accelerated studies there was not significant product degradation. Under above mentioned conditions two years were established as expiring date.


REFERENCES

  1. Goodman A, Gilman A. Las bases farmacológicas de la terapéutica. Tomo II. 3ra ed. La Habana: Editorial Científico Técnica; 1994. p. 4665. (Edición Revolucionaria).

  2. PDR. Physician´s Desk Reference. 57 ed. New York: Inc at Montuale; 2003. p. 2198.

  3. Dierksneier G. Métodos cromatograficos. La Habana: Ed. Científico-Técnica; 2005. p. 1-4, 256-412.

  4. International Conference on Harmonization. Validation of Analytical Procedures. Technical Requirements for the Registration of Pharmaceuticals for Human Use.Geneva: ICH-Q2A; 1995.

  5. Farmacopea de los Estados Unidos. USP 30. The United States Pharmacopeial Convention. Estados Unidos de América NF-25. 2007. 30 ed. Rockville: Mack Printing; 2007.

  6. Regulación No. 16-2000: Buenas Prácticas de Fabricación de Productos Farmacéuticos. La Habana: Centro Estatal para el Control de Medicamentos (CECMED); 2000.

  7. García Peña CM, León Rodríguez R, Fernández Cervera M, Ibáñez Calvo S, Martínez Espinosa V. Evaluación de desempeño del método de ensayo de disolución para tabletas de zidovudina 300 mg producidas en Cuba. Rev Cubana Farm [Internet]. 2010 Sep [citado 2010 Feb 05]; 44(3): 297-305. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152010000300003&lng=es




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C?MO CITAR (Vancouver)

Rev Cubana Farm. 2011;45