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Establishment of content criteria of marker compounds through the monitoring of Achyranthis Radix collected from Korea and China

한국 및 중국 지역에서 수집된 우슬의 모니터링을 통한 지표성분의 함량기준 설정

  • Kim, Dae-Hyun (College of Pharmacy, Chungnam National University) ;
  • Kim, Sang-Hyuk (College of Pharmacy, Chungnam National University) ;
  • Jang, Yu-Seon (Institute of Drug Research & Development, Chungnam National University) ;
  • Shin, Min-Chul (College of Pharmacy, Chungnam National University) ;
  • Chu, Van Men (College of Pharmacy, Chungnam National University) ;
  • Lee, Young-Keun (Daejeon Health Sciences College) ;
  • Woo, Mi-Hee (College of Pharmacy, Catholic University of Daegu) ;
  • Kang, Jong-Seong (College of Pharmacy, Chungnam National University)
  • Received : 2012.03.16
  • Accepted : 2012.07.30
  • Published : 2012.08.25

Abstract

Two marker compounds of Achyranthis Radix, ecdysterone and inokosterone, were analyzed by HPLC on an ODS column ($250{\times}4.6$ mm, 5 ${\mu}m$) with a mobile phase of 15% acetonitrile containing 0.08% formic acid at a flow rate of 1.0 mL/min and a detection wavelength of UV 254 nm. The method was validated by ICH guideline and applied to the monitoring of marker compounds in 93 samples of Achyranthis Radix collected at various areas in Korea and China. The new content criteria of ecdysterone and inokosterone, established using linear regression method were 0.033% and 0.020%, respectively. When the new content criteria were applied to the quality control test of commercial Achyranthis Radix, 95.4% of total samples including 100% of Korean and 92.6% of Chinese samples were passed the test. Application of new content criteria could protect the Korean products and decrease the distribution of Chinese products with lower quality.

Keywords

content criteria;ecdysterone;inokosterone;Achyranthis Radix;HPLC

Acknowledgement

Supported by : 식품의약품안전청

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