Ceftaroline fosamil: development a rapid HPLC method indicating stability and bioassay for determination in pharmaceutical formulation, stability and cytotoxicity studies

The present study reports the development and validation of a microbiological assay. To assess this methodology, method was developed validated for quantification CEF by high performance liquid chromatography (HPLC). microbial assay diffusion in 3x3 cylinder agar presented showed satisfactory results as to specificity, linearity range 2.0 - 8.0 ?g.mL-1, precision (109.42 %), accuracy (102.3 robustness. HPLC were evaluated according linearity, precision, A from Shimadzu with Agilent® C18 column, mobile phase (water triethylamine 1.0 % pH 5.0: acetonitrile 87:13 v/v used chromatographic method. methods compared statistically there no significant difference between them when Student's t-test. In preliminary stability study, it found stable acid hydrolysis (0.1M) UVA light period evaluated, unstable against thermal degradation (40 60 °C), oxidative hydrogen peroxide, basic NaOH (0.1 M 0.01M) UVC light. Samples exposed at 60°C kinetics following zero order second order, respectively. cytotoxicity normal condition sample submitted forced degradation, suggesting that possible products formed did not change result. difference, therefore, they are interchangeable, so can be routine quality control analysis.