Development and validation of physicochemical method for quantification of spiramycin in tablets

Spiramycin, macrolide antibiotic, is obtained by fermentation of Streptomyces ambofaciens1 and acts on the organism by inhibiting bacterial protein synthesis. Studies on the development of analytical methods for quality control of spiramycin (1.5 MUI) become indispensable for proving quality, safety and clinical efficacy. The aim of this work was to develop and validate an analytical methodology for quantifying spiramycin by multivariate optimization using experimental designs. HPLC analysis were carried out using UV/HPLC grade reagents and solvents. A 23 full factorial design was initially performed. The data obtained was used to establish the best chromatographic conditions for the response surface methodology. Preliminary results showed that the temperature does not influence analytical response and the parameters used in the final optimization showed that the ratio of methanol (33%) and mobile phase flow rate (1.0 mL.min-1) were satisfactory. The method validation was applied following the requirements of RDC nº 166/2017.