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ISSN 1561-2988 (Print)

2011, Number 2

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Rev Cubana Farm 2011; 45 (2)

Validation of the analytical method to quantify the bacitracine

Velandia-Castellanos C; Peña-Páez V; Arias-Palacios J

Language: Spanish
References: 7
Page: 216-225
PDF size: 72.86 Kb.


ABSTRACT

An analytical method was developed and validated for quantitative determination of 15 % zinc bacitracine and 11 % disalicylate methylene-bacitracine by the platecylinder method (agar diffusion) to be used in quality control of raw products and pharmaceutical products. Specificity, selectivity, system and method linearity, accuracy, quantification and precision parameters were assessed. By the experimental design and the statistic evaluation of results, it was demonstrated that the analytical method is specific, selective, linear, precise (CV< 5 %) and exact (bias < 3 %, Gexp< Gtab< texp< ttab) during the study concentrations. The quantification and detection limit was of 0.02 and 0.005 Ul/mL, respectively. The analytical performance characteristics fulfill the requirement for the proposal analytical implementation.


REFERENCES

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  2. United States Pharmacopoeial Convention. USP 30. Validación de procedimientos farmacopeicos. 30 ed. Rockville: Mack Printing; 2007. p. 749.

  3. United States Pharmacopoeia Convention. USP 30. Antibióticos. Valoraciones microbiológicas. 30 ed. Rockville: Mack Printing; 2007. p .81-111.

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