Journal of the Korean Applied Science and Technology (한국응용과학기술학회지)

The Korean Society of Applied Science and Technology (한국응용과학기술학회)
권호 표지
DOI QR코드

DOI QR Code

Necessity of high-performance liquid chromatography validation in good laboratory practice systems

비임상시험관리기준 시스템에서 고성능액체크로마토그래피 분석법 정확도 검증의 필요성

  • Su Bin Yang (Department of Toxicity Assessment, Daegu Catholic University) ;
  • Changyul Kim (Department of Toxicity Assessment, Daegu Catholic University)
  • 양수빈 (대구가톨릭대학교 화학물질독성평가학과) ;
  • 김창열 (대구가톨릭대학교 화학물질독성평가학과)
  • Received : 2024.02.29
  • Accepted : 2024.03.27
  • Published : 2024.04.30
Download PDF
⟨ Previous Next ⟩

Abstract

In good laboratory practice (GLP), analytical method validation prior to toxicity testing is important in terms of concentration setting and sample preparation. The testing agency performed validation of the two requested test substances using high-performance liquid chromatography (HPLC), and as a result, the analysis satisfied the criteria for specificity, system suitability, linearity, intra-day reproducibility, homogeneity, stability, concentration analysis, and quality control. The method was established and validated. However, the content of standard substances in the test report of the requesting institution was found to be 1.34 and 1.17 times higher than the results of the testing institution, confirming that deriving results through validation of analysis methods suitable for GLP is important in terms of securing reliability and stability.

비임상시험관리기준에서 독성시험 전 분석법 밸리데이션은 농도 설정 및 시료 제조 측면에서 중요하다. 시험기관에서는 의뢰받은 시험물질 2종에 대한 밸리데이션을 고성능액체크로마토그래피를 이용하여 수행한 결과 특이성, 시스템 적합성, 직선성, 일내 재현성, 균질성, 안정성, 농도분석, 품질관리를 판정 기준에 만족하는 분석방법을 확립 및 검증하였다. 하지만 의뢰기관의 시험성적서상 표준물질 함량은 시험기관의 결과보다 1.34배, 1.17배 높은 결과로 나타나 비임상시험관리기준에 적합한 분석법 밸리데이션을 통한 결과 도출이 신뢰성과 안정성 확보 측면에서 중요함을 확인하였다.

Keywords

Acknowledgement

본 연구는 한국화학물질관리협회 화학물질 안전관리 전문인력 양성 사업의 지원을 받아 수행되었음.

References

  1. Ministry of food and drug safety. Good laboratory practice commentary. Chungcheongbuk-do, (2017).
  2. J. A. Hwang, D. H. Kim, C. C. Shin, E. J. Lee, N. S. Choi, J. S. Gam, "A Study on Establishment of Good Laboratory Practice Guidebook", Regulatory Research on Food, Drug and Cosmetic. Vol.15, No.1 pp. 9-18, (2020).
  3. H. Kim, A. R. Scialli, "Thalidomide: The Tragedy of Birth Defects and the Effective Treatment of Disease", Toxicological Sciences, Vol.122, No.1 pp. 1-6, (2011). https://doi.org/10.1093/toxsci/kfr088
  4. J. Y. Han, J. G. Cho, J. M. Oh, "Necessity of Research for Safe Drug use in Pregnant Women", Journal of the Korean Society of Maternal and Child Health. Vol.21, No.3 pp. 159-165, (2017). https://doi.org/10.21896/jksmch.2017.21.3.159
  5. N. Vargesson, "Thalidomide-induced teratogenesis: History and mechanisms", Birth Defects Research Part C: Embryo Today: Reviews. Vol.105, No.2 pp.140-156, (2015). https://doi.org/10.1002/bdrc.21096
  6. Good Laboratory Practice (GLP), "https://www.oecd.org/chemicalsafety/testing/good-laboratory-practiceglp.htm", Organisation for economic co-operation and development, (2024).
  7. Ministry of food and drug safety. KGLP commentary. Chungcheongbuk-do, (2014).
  8. Ministry of food and drug safety, "Guide to preparing submission materials for recognition of functional health food ingredients", Chungcheongbuk-do, (2022).
  9. E. Lee, K. Song, I. Yu, "Characterization of test substance in the GLP", Journal of toxicology and public health, Vol.23, No.2 pp. 173-177, (2007). https://doi.org/10.5487/TR.2007.23.2.173
  10. K. H. Cho, J. S. Kim, M. S. Jeon, K. H. Lee, M. K. Chung, C. W. Song. "Basic Principles of the Validation for Good Laboratory Practice Institutes", Toxicological Research, Vol.25, No.1 pp. 1-8, (2009). https://doi.org/10.5487/TR.2009.25.1.001
  11. U.S. Food&Drug Administration. Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry. (2015).
  12. EUROPEAN MEDICINES ANGECY. ICH guideline Q2(R2) on validation of analytical procedures. (2022).
  13. M. L. Whitmire, P. Bryan, T. R. Henry, J. Holbrook, P. Lehmann, T. Mollitor, S. Ohorodnik, D. Reed, H. D. Wietgrefe, "NonClinical dose formulation analysis method validation and sample analysis", The AAPS Journal. Vol.12, No.4 pp. 628-623, (2010).
  14. M. Whitmire, R. Ross, J. Mwalimu1, L. Porter, M. Whitse, "A Global GLP Approach to Formulation Analysis Method Validation and Sample Analysis", Pharmaceutica Analytica Acta. No.S2 pp. 1-7, (2011).
  15. U.S. Food&Drug Administration. Good Laboratory Practice for Nonclinical Laboratory Studies. (2010).
  16. D. W. Huntsinger, "OECD and USA GLP applications", Ann Ist Super Sanita, Vol.44, No.4 pp. 403-406, (2008).