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Revista Cubana de Farmacia

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2013, Number 4

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Rev Cubana Farm 2013; 47 (4)

Analytical performance of the quality control methods in a concentrated solution for hemodialysis

Benavides PJC, Rojas RR, Rodríguez AJR, Lafourcade PA
Full text How to cite this article

Language: Spanish
References: 8
Page: 427-435
PDF size: 93.78 Kb.


Key words:

validation, haemodialysis, analytical performance.

ABSTRACT

Objective: to evaluate the analytical performance of the sodium, potassium, chloride, calcium and magnesium ions quantification methods, in a concentrated solution with bicarbonate for hemodyalisis.
Methods: the five analytical methods are reported on the official British pharmacopeia. The performance evaluation was made by verifying linearity, accuracy and precision. In all cases, the enriched placebo method was used, with concentration levels from 60 to 140 % of the standard concentration value of each ion.
Results: the five methods showed linearity in the evaluated concentration range; they were accurate and precise with global variation coefficients lower than 1.75 %, and a recovery rate of 100 ± 3 %.
Conclusions: the quantification methods for the ions present in concentrated solution with bicarbonate for hemodialysis, allows obtaining reliable results under the analytical conditions used in this research.


REFERENCES

  1. Gunter W, Eberhard R. Tratamiento combinado con inhibiciones de la ECA y bloqueantes de la angiotensina II para detener la progresión de la enfermedad renal crónica: fisiopatología e indicaciones. Kidney Internacional. 2005;1(1):1-14.

  2. Pérez-Oliva Díaz JF, Magrans BC, Almaguer LM, Zambrano CAE, Delgado G, Pérez CR, et al. Guías de buenas prácticas en hemodiálisis. La Habana: INNEF; 2003.

  3. United States Pharmacopoeia. The official compendia of standard. Rockville: Mack Printing; 2007. [CD-ROM].

  4. Pecoits R, Abensur H, Cueto MAM, Domínguez J, Divino JC, Fernández CJ. Overview of peritoneal dialysis in Latin America. Perit Dial Int. 2007;27:316-21.

  5. British Pharmacopoeia. London: Stationary Office; 2010. [CD-ROM].

  6. Guide Eurachem. The Fitness for Purpose of Analytical Methods: A laboratory Guide to Method Validation and Related Topics. 2003. [First english edition].

  7. MINSAP. Centro para el Control Estatal de la Calidad de los Medicamentos. Regulación 47/2007. Validación de métodos analíticos. La Habana: MINSAP; 2006.

  8. Skoog D, West DM. Introducción a la química analítica. Barcelona: Editorial Reverté; 1980. p. 257-63.




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C?MO CITAR (Vancouver)

Rev Cubana Farm. 2013;47