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- Title
Miniaturized Microbiological Method to Determine the Potency of Rifaximin in Tablets.
- Authors
Motta Correa, Clara Bersi; Carolina Kogawa, Ana; Chorilli, Marlus; Nunes Salgado, Hérida Regina
- Abstract
Background: Rifaximin, a semi-synthetic antimicrobial, does not present microbiological method described in official compendia, and there is a lack of literature on this topic. The quality control of antimicrobials is extremely important to evaluate the real potency of pharmaceutical products. Objective: A miniaturized turbidimetric method for determining the potency of rifaximin in tablets was developed and validated by turbidimetry, according to the international guidelines. Method: Escherichia coli ATCC 10536 IAL 2393, brain heart infusion (BHI) broth, inoculum at 8%, rifaximin in purified water with 20% ethanol at 5, 10, and 20 lg/mL and 530nm were used. Results: The method was considered selective for rifaximin, as the adjuvants did not show activity; linear with correlation coefficients 0.9998 for standard and 0.9999 for sample; accurate with 99.73% recovery; precise with RSD less than 3%; and robust in the face of small variations in (i) rifaximin volume, (ii) proportion of ethanol, (iii) inoculum volume. Conclusions: The method is considered adequate and safe to evaluate the potency of rifaximin in tablets, contemplating speed, low cost, low waste generation, and ease of operation. Highlights: This work usescurrent, sustainable, and green analytical chemistry and can be used in the routine analyses of rifaximin by laboratories and the pharmaceutical industry around the world.
- Subjects
ANALYTICAL chemistry; SUSTAINABLE chemistry; QUALITY control; ESCHERICHIA coli; STATISTICAL correlation; RIFAXIMIN
- Publication
Journal of AOAC International, 2021, Vol 104, Issue 4, p1049
- ISSN
1060-3271
- Publication type
Article
- DOI
10.1093/jaoacint/qsab017