Abstract

VELANDIA-CASTELLANOS, Carolina; PENA-PAEZ, Viviana  and  ARIAS-PALACIOS, Janeth. Validation of the analytical method to quantify the bacitracine. Rev Cubana Farm [online]. 2011, vol.45, n.2, pp. 216-225. ISSN 1561-2988.

An analytical method was developed and validated for quantitative determination of 15 % zinc bacitracine and 11 % disalicylate methylene-bacitracine by the plate-cylinder 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 %, G_exp< G_tab< t_exp< t_tab) 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.

Keywords : Bacitracin; quality control; agar-diffusion; pharmaceutical industry; microbiological validation.

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