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Validation and Routine Application of a Versatile Bioassay for Quantification of Ertapenem Sodium

Tahisa Marcela Pedroso, Ana Carolina Kogawa, Hérida Regina Nunes Salgado

An effective therapeutic agent is essential for the control of many infectious diseases which can predict for the present time social and economic high costs. Ertapenem sodium (ERTM) is a synthetic antimicrobial agent of the class of carbapenems that have action against Gram-negative, Gram-positive, aerobic and anaerobic microorganisms. The lack of new effective antibiotics against multidrug-resistant pathogens is a constant concern. The progress of resistance to carbapenems is an alarming problem, since those are considered one of the most important drugs for the treatment of severe infections caused by enterobacteria. Thus, it is necessary to investigate the changes in the pharmacological profile of carbapenems. Microbiological methods are required for an antimicrobial effectiveness evaluation. In turbidimetric assay, the potency of a drug is determined by measuring the turbidity (absorbance), caused by the inhibition of microorganisms. This study presents an efficient, accurate, reproducible, low cost and microbiological assay which is highly relevant in the pharmaceutical industry to quantify ertapenem sodium. For performing the method, Staphylococcus aureus (ATCC 26923) was used as the test microorganism and the culture medium chosen was the Brain Heart Infusion broth - as the BHI. Validation parameters were in accordance with the specifications of ICH and demonstrated accuracy, precision, selectivity and robustness, with linear tracks 12.80; 16.00 and 20.00 μg mL-1. The turbidimetric assay is more versatile, faster and easier to apply than agar diffusion one. The method is simple and can be used in routine analysis of quality control of ertapenem sodium in the pharmaceutical industry.