- P-ISSN 1225-0163
- E-ISSN 2288-8985
- P-ISSN1225-0163
- E-ISSN2288-8985
- SCOPUS, ESCI, KCI
Article Detail
Home > Article Detail
Purity assignment of 17β-estradiol by mass balance method
Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2017, v.30 no.5, pp.226-233
https://doi.org/10.5806/AST.2017.30.5.226
&
(2017). Purity assignment of 17β-estradiol by mass balance method. Analytical Science and Technology, 30(5), 226-233, https://doi.org/10.5806/AST.2017.30.5.226
- Downloaded
- Viewed
Abstract
In general, quantitative chemical analysis in various areas including food, the environment, in vitro diagnostics, etc., requires traceability in order to increase the reliability of the measurements. Measurement traceability is a property of an unbroken chain of comparisons relating an instrument's measurements to SI units. Purity analysis is the first process for establishing traceability to SI units in chemical measurements. The purpose of this study is to develop and validate a method of purity assignment for establishing the traceability of 17β-estradiol measurements in an in vitro diagnostics field. The establishment of this method is very important as it can be applied to the development of CRM and to the analysis of the purity of other hormones. The method of assignment of the purity of 17β-estradiol was developed using the mass balance method and was validated through participation in an International comparison. In the mass balance method, impurities are categorized into four classes as follows: total related structure impurities, water, residual organic solvents, and nonvolatiles/inorganics. In this study, total related structure impurities were characterized by a gas chromatography-flame ionization detector (GC-FID) and a high-performance liquid chromatography-ultraviolet (HPLC-UV) detector, water content was determined by a Karl-Fisher coulometer, and total residual solvents and nonvolatiles/inorganics were checked simultaneously by thermogravimetric analysis (TGA). The purity of the 17β- estradiol was 985.6 mg/g and the expanded uncertainty was 2.1 mg/g at 95% confidence. The developed method can be applied to the development of certified reference materials, which play a critical role in traceability.
- keywords
- <TEX>$17{\beta}$</TEX>-estradiol, purity analysis, mass balance method, traceability, certified reference material
Reference
1
1. ISO/IEC 17025 (2005).
2
2. European Council Directive 98/79/EC (1998).
3
3. ISO 17511 (2003).
4
4. H. S. Lee, S. J. Park, E. J. Ahn, S. K. Kim, G. H. Lee and M. S. Kim, Bull. Kor. Chem. Soc., 37(3), 418-421(2016).
5
5. S. Westwood, T. Choteau, A. Daireaux, R. D. Josephs and R. I. Wielgosz, Anal. Chem., 85, 3118 (2013).
6
6. S. Westwood, R. D. Josephs, A. Daireaux and R. Wielgosz, et al., Metrologia, 46(1A), 08019 (2009).
7
7. S. Westwood, R. D. Josephs, T. Choteau, C. Mesquida, A. Daireaux and R. Wielgosz, et al., Metrologia, 48(1A), 08013 (2011).
8
8. S. Westwood, R. D. Josephs, A. Daireaux and R. Wielgosz, et al., Metrologia, 49(1A), 08009 (2012).
9
9. S. Westwood, R. D. Josephs, T. Choteau, A. Daireaux and R. Wielgosz, et al., Metrologia, 49(1A), 08014 (2012).
10
10. J. F. Strauss and R. L. Barbieri, Yen and Jaffe's Reproductive Endocrinology: Physiology, Pathophysiology, and Clinical Management, Elsevier Health Sciences, 807 (2009).
11
11. J. B. Becker, K. J. Berkley, N. Geary, E. Hampson, J. P. Herman and E. Young, Sex Differences in the Brain:From Genes to Behavior, Oxford University Press, 64(2007).
12
12. I. D. Hay and J. A. H. Wass, Clinical Endocrine Oncology, John Wiley & Sons, 623 (2009).
13
13. R. F. Dons, Endocrine and Metabolic Testing Manual, CRC Press, 8 (1994).
14
14. R. Stricker, R. Eberhart, M. C. Chevailler, F. A. Quinn, P. Bischof and R. Stricker, Clin. Chem. Lab. Med., 44(7), 883-887 (2006).
15
15. C. H. Wu, T. Motohashi, H. A. Abdel-Rahman, G. L. Flickinger and G. Mikhail, J. Clin. Endocrinol. Metab, 43(2), 436-445 (1976).
16
16. R. Södergård, T. Bäckström, V. Shanbhag and H. Carstensen, J. Steroid Biochem., 16(6), 801-10 (1982).
17
17. JCGM, Evaluation of measurement data—guide to the expression of uncertainty in measurement, JCGM, 100(2008).
18
18. JCGM. International Vocabulary of Metrology−Basic and General Concepts and Terms, JCGM, 200 (2012).
Other articles from this issue
- An HPLC method for the determination of thioctic acid in raw material and tablets
- Purity assignment of 17β-estradiol by mass balance method
- Thermal residues analysis of plastics by FT-near infrared spectroscopy
- Determination of trace impurities of HFC-134a by gas chromatograph with atomic emission detector (GC/AED)
- Method development for quantitative analysis of naturally occurring radioactive nuclides in building materials
- Distribution of natural radionuclide in the Geum river sediment
- The study on the penetration and washing features of blood on the surface of fabric
- A preliminary study to determine the order of the latent fingerprint deposition on thermal paper − A short term study −
- Development of standard gas mixtures of hydrocarbons in methane contained in aluminum cylinders
- Analytical method validation and monitoring of levulinic acid in soy sauce and their application to food
- more
Recommanded Articles
This website recommended the use the Chrome browser for journal website.