Analytical Science and Technology (분석과학)

The Korean Society of Analytical Sciences (한국분석과학회)
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Development of HPLC assay method of fusidate sodium tablets

  • Lee, GaJin (College of Pharmacy, Kangwon National University) ;
  • Choi, Min (College of Pharmacy, Kangwon National University) ;
  • Truong, Quoc-Ky (College of Pharmacy, Kangwon National University) ;
  • Mai, Xuan-Lan (College of Pharmacy, Kangwon National University) ;
  • Kang, Jong-Seong (College of Pharmacy, Chungnam National University) ;
  • Woo, Mi Hee (College of Pharmacy, Catholic University of Daegu) ;
  • Na, Dong-Hee (College of Pharmacy, Chungang University) ;
  • Chun, In-Koo (The Society of Korean Official Compendium for Public Health) ;
  • Kim, Kyeong Ho (College of Pharmacy, Kangwon National University)
  • Received : 2017.05.10
  • Accepted : 2017.06.14
  • Published : 2017.06.25
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Abstract

The Korean Pharmacopoeia (KP XI), British Pharmacopoeia (BP 2013) and Japanese Pharmacopoeia contain monographs for the quality control of raw fusidate sodium and its formulations using high performance liquid chromatography (HPLC). However, the assay method for the determination of fusidate sodium in commercial tablets is titration which is less specific than HPLC. In this study, we present an alternative HPLC method for quantitation of fusidate sodium in tablets. Method validation was performed to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of calibration curves in the desired concentration range was high ($r^2=0.9999$), while the RSDs for intra- and inter-day precision were 0.25-0.37 % and 0.11-0.60 %, respectively. Accuracies ranged from 99.46-100.85 %. Since the system suitability, intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).

Keywords

Acknowledgement

Supported by : Ministry of Food and Drug Safety

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