Development and validation of microbiological assay by agar diffusion method - cylinder plate for doripenem powder for injectable solution

Abstract

The carbapenems are a class of -lactam antibiotics that present action against Gram-positive and Gram-negative bacteria. Doripenem is a new carbapenem that has few published studies for the quantitative determination and there isn’t monograph in the Official Codes. Therefore, this study aims to develop and validate microbiological assay for quality control of the drug powder for injectable solution. The parameters analyzed during validation were linearity (r=0.99999), repeatability (RSD=1.74%), intermediate precision (RSD=3.12%), accuracy (98.90 to 101.51%), specificity and robustness. The results show that the method is suitable for quality control of doripenem powder for injectable solution