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Development of alternative assay method without hazardous reagent, carbon tetrachloride, for cefroxadine capsules in Korean Pharmaceutical Codex

세프록사딘 캡슐 시험에 사용되는 유해시약인 사염화탄소 대체 공정시험법 개발

  • Received : 2014.02.24
  • Accepted : 2014.06.07
  • Published : 2014.06.25

Abstract

Currently oxidation-reduction titration method for the assay method using the hazardous reagent, carbon tetrachloride, for cefroxadine capsules has been used in Korean Pharmaceutical Codex. We developed and validated an alternative HPLC assay method by substituting the use of the hazardous reagent, carbon tetrachloride, to the use of less toxic ones like acetonitrile. The linearity of the calibration curves in the desired concentration range was good ($r^2$ > 0.999). Relative standard deviations of intra-day precision were ranged between 0.30% and 0.69% and inter-day precision were ranged between 0.47% and 0.82%. Accuracy was obtained with recoveries in range of 100.20% and 100.56%. Developed method was applied to the determination of cefroxadine in commercial cefroxadine capsule and could be expected to become valuable tools for revising the Korean Pharmaceutical Codex.

Keywords

Korean Pharmaceutical Codex;hazardous reagents;alternative testing methods;validation;high performance liquid chromatography

Acknowledgement

Supported by : 식품의약품안전처

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