본 연구는 건강기능식품의 복합제품 개발 및 일반식품 형태의 제품개발 확대에 따라 옥타코사놀의 특이성 및 감도 등이 개선된 분석법을 마련하여 향후 공정시험법에 활용할 수 있도록 하였다. 건강기능식품 중 옥타코사놀의 함량분석을 위해 GC-MS를 이용한 분석법을 확립하고 유통중인 제품을 대상으로 적용성을 검토하였다. 분석법 검증은 특이성, 직선성, 검출한계 및 정량한계, 정확성, 정밀성에 대해 수행하였다. 12.5~200.0 μg/L의 농도범위에서 r2 = 0.999 이상의 우수한 직선성을 확인할 수 있었으며, 검 출한계와 정량한계는 각각 4.5, 13.8 μg/L이었다. 공시료에 표준물질 첨가법을 이용하여 정확성을 검토하였으며 50, 100, 150 μg/L의 농도에서 각각 94, 93, 109%의 회수율을 확인할 수 있었다. 정밀성 결과에서는 시료 채취량을 80 mg, 120 mg, 220 mg으로 각기 달라하여 측정한 결과 상대표준편차는 1.8~2.4%로 확인되었다. 실험실간재현성은 1.0~2.3%로 나타났다. 본 연구에서 확립된 분석법을 적용하여 유통제품 9건에 대해 적용성 검토를 실시한 결과 전체 시료에서 분석이 용이하였으며, 모두 표시기준에 적합함을 확인하였다.
본 연구를 통하여 확립된 GC-MS를 이용한 건강기능식품 중 옥타코사놀 분석법은 향후 공정시험법으로 활용할 수 있으며 국내 건강기능식품의 관리 기반을 강화하는데 기여할 것으로 사료된다.

The Ministry of Food and Drug Safety (MFDS) is amending its test methods for health-functional foods (dietary food supplements) to establish regulatory standards and specifications in Korea. In this regard, we continue our research on developing analytical methods for the items. Octacosanol is the major component of polycosanol andis a high-molecular-mass primary fatty alcohol, obtained from sugar cane wax. Previous researchers have shown that octacosanol can lower cholesterol and has antiaggregatory properties, cytoprotective uses, and ergogenic properties for human health. Recently, octacosanol products have been actively introduced into the domestic market because of their functional biological activity. We have developed a sensitive and selective test method for octacosanol that the TMS derivatives by means of gas-chromatographictandem mass spectrometry (GC-MS).The trimethylsilyl ether derivative of the target analyte showed excellent chromatographic properties. The procedure was validated in the range of 12.5 ~ 200 ㎍/ℓ. Standard calibration curves presented linearity with the correlation coefficient (r2) > 0.999, and the limits of detection (LOD) and limits of quantitation (LOQ) were 4.5 ㎍/L and 13.8 ㎍/L, respectively. The high recoveries (92.5 to 108.8 %) and precision (1.8 to 2.4 %) obtained are in accordance with the established validation criteria. Our research can provide scientific evidence to amend the octacosanol test method for the Health-Functional Food Code.

ABSTRACT
 Materials and Methods
  시약 및 시료
  표준원액 및 표준용액의 조제
  시료의 전처리
  GC-MS 분석조건
  분석법 유효성 검증
 Results and Discussion
  특이성 및 직선성
  검출한계 및 정량한계
  정확도 및 정밀도
  실험실간 교차검증
  분석법의 적용성 검토
  건강기능식품공전 시험법 비교 검토
 국문요약
 References

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