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Development of alternative assay method without hazardous reagent, carbon tetrachloride, for cefroxadine capsules in Korean Pharmaceutical Codex
Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2014, v.27 no.3, pp.161-166
https://doi.org/10.5806/AST.2014.27.3.161
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(2014). Development of alternative assay method without hazardous reagent, carbon tetrachloride, for cefroxadine capsules in Korean Pharmaceutical Codex. Analytical Science and Technology, 27(3), 161-166, https://doi.org/10.5806/AST.2014.27.3.161
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Abstract
국가공정서 중 하나인 대한민국약전외의약품기준에는 세프록사딘 캡슐의 정량법으로 유해시약인 사염화탄소를 사용하는 산화환원분석법이 수재되어 있다. 세프록사딘 캡슐의 환경 친화적인 대체 시험법으로 보다 안전하고 효율적인 친환경용매를 사용하는 HPLC 분석법을 개발하고, 이를 검증하였다. 직선성은 상관계수(r2)가 0.999이상으로 우수하였다. 일내 정밀도는 상대표준편차 0.30~0.69%, 일간 정밀도는 0.47~0.82%로, 회수율은 100.20~100.56%로 나타났다. 개발한 시험법을 이용하여 시중 유통 중인 세프록사딘 캡슐 중 세프록사딘의 함량측정에 응용하였다. 개발된 시험법은 대한민국약전외의약품기준의개정에 기여가 될 것이다.
- keywords
- Korean Pharmaceutical Codex, hazardous reagents, alternative testing methods, validation, high performance liquid chromatography
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