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Mass balance법에 의한 농약 표준물질의 순도 분석

Mass Balance Method for Purity Assessment for Pesticide Analytical Standards

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초록

Imazamox, a widely used herbicide, is currently managed by the Pesticide MRLs and Positive List System of the Ministry of Food and Drug Safety, and the development of reliable standard materials for analysis is urgently required. To confirm the reliability of the mass balance method, we measured the purity of the imazamox reference material (RM) certified by an RM producer accredited with ISO Guide 34 and estimated measurement uncertainty. According to this method, the content of structurally similar organic impurities was measured using high-performance liquid chromatographic coupled with ultraviolet (HPLC-UV), and the moisture, volatile impurities, and non-volatile impurities were quantitatively analyzed using a thermogravimetric analyzer (TGA). Purity and measurement uncertainty were calculated based on analysis of the HPLC-UV and TGA results obtained, and the validity of these values was confirmed by comparing with the values provided in the RM certificate.

Abstract

Imazamox, a widely used herbicide, is currently managed by the Pesticide MRLs and Positive List System of the Ministry of Food and Drug Safety, and the development of reliable standard materials for analysis is urgently required. To confirm the reliability of the mass balance method, we measured the purity of the imazamox reference material (RM) certified by an RM producer accredited with ISO Guide 34 and estimated measurement uncertainty. According to this method, the content of structurally similar organic impurities was measured using high-performance liquid chromatographic coupled with ultraviolet (HPLC-UV), and the moisture, volatile impurities, and non-volatile impurities were quantitatively analyzed using a thermogravimetric analyzer (TGA). Purity and measurement uncertainty were calculated based on analysis of the HPLC-UV and TGA results obtained, and the validity of these values was confirmed by comparing with the values provided in the RM certificate.

참고문헌 (18)

  1. D. Giron, "Place of DSC purity analysis in pharmaceutical development", Journal of Thermal Analysis, 44, pp.217~251 (1995)
  2. Standard Test Method for Purity by Differential Scanning Calorimetry, "America Society for Testing and Materials (ASTM)International", ASTM, ~, pp.E 928-08 (2014)
  3. S. Mathkar, "The use of differential scanning calorimetry for the purity verification of pharmaceutical reference standards", Journal of Pharmaceutical and Biomedical Analysis, 49, pp.627~631 (2009)
  4. F. Malz, "Validation of quantitative NMR", Journal of Pharmaceutical and Biomedical Analysis, 38, pp.813~823 (2005)
  5. U. Holzgrabe, "Quantitative NMR spectroscopy in phar"maceutical applications", Progress in Nuclear Magnetic Resonance Spectroscopy, 57, pp.229~240 (2010)
  6. International Organization for Standardization, "Reference materials-general and statistical principles for certification", ISO Guide 35, ~ (2006)
  7. "ICH Q3A(R2) Guideline, Impurities in new drug substances", ~ (2006)
  8. 김승현, "Purity Assessment of Organic Reference Materials with a Mass Balance Method: A Case Study of Endosulfan-II", Bulletin of the Korean Chemical Society, 34(2), pp.531~538 (2013), 대한화학회
  9. S. Westwood, "Mass Balance Method for the SI Value Assignment of the Purity of Organic Compounds", Analytical Chemistry, 85, pp.3118~3126 (2013)
  10. Hwa Shim Lee, "Purity assignment of 17α-hydroxyprogesterone by mass balance method to establish traceability in measurement", 분석과학, 32(6), pp.225~232 (2019), 한국분석과학회
  11. S. R. Davies, "The development of an efficient mass balance approach for the purity assignment of organic calibration standards", Analytical Bioanalytical Chemistry, 407, pp.7983~7993 (2015)
  12. 이준희, "Mass Balance Method for Purity Assessment of Organic Reference Materials: for Thermolabile Materials with LC-UV Method", Bulletin of the Korean Chemical Society, 35(11), pp.3275~3279 (2014), 대한화학회[DOI]
  13. Sunyoung Lee, "Purity Assessment of Monosaccharides using Mass Balance Method", Bulletin of the Korean Chemical Society, 41(10), pp.1002~1008 (2020), 대한화학회[DOI]
  14. K. A. Nelson, "Weed control in soybean (Glycine max) with imazamox and imazethapyr", Weed science, 46, pp.587~594 (1998)
  15. S. Tan, "Imidazolinone-tolerant crops: history, current status and future", Pest Management Science, 61, pp.246~257 (2005)
  16. Ç. Sevim, "An imazamox-based herbicide causes apoptotic changes in rat liver and pancreas", Toxicology Reports, 6, pp.42~50 (2019)
  17. H. Arda, "Physiological and Genetic Effects of Imazamox Treatment on Imidazolinone-Sensitive and Resistant Sunflower Hybrids", Water Air Soil Pollut, 118, pp.1~12 (2020)
  18. International Organization for Standardization, "Statistical methods for use in proficiency testing by interlaboratory comparison", ISO 13528, ~ (2015)

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