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KMID : 1142220210160010007
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 1 p.7 ~ p.17
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Comparison of Antibiotic Potency Test Methods in Korean Pharmacopoeia with United States, Japanese, and European Pharmacopoeias
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Lee Eun-Goo
Yoon Ji-Hyun
Kwon Sung-Won
Lee Seul-Ji
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Abstract
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Antibiotics are drugs that are specifically used to treat and prevent bacterial infections. Antibiotic consumption is much higher in Korea than in other OECD countries. According to the OECD Health Statistics 2020, antibiotic consumption was reported to be the third highest in Korea following Turkey and Greece. The exact amount of systematic antibiotic consumption in Korea is 38.7 daily defined doses, approximately 1.9 times higher than the average antibiotic consumption in all OECD countries. The potency test of a total of 185 antibiotics has been included in the Korean Pharmacopoeia (Twelfth edition)「Monographs」section. Evaluating the exact content and potency of antibiotics can assist in minimizing associated side effects. Microbiological assay, potentiometric titration, liquid chromatography, UV-Visible spectrophotometry, redox titration using iodine, standard curve method, and gas chromatography have been used previously to evaluate antibiotic potency in the Korean Pharmacopeia. Herein, we compared the antibiotic potency tests in the Korean Pharmacopeia with the United States, Japanese, and European Pharmacopeias for these 185 antibiotics as the starting material. We found that liquid chromatography, a contemporary analytical technique with high precision and accuracy, has been frequently used in other countries. Following the general trend, it is expected that there will be advancement and standardization of quality control methods, further strengthening the competitiveness in the overseas marke
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KEYWORD
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Antibiotics, Potency test, Korean Pharmacopoeia, Quality control method
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