Araştırma Makalesi
BibTex RIS Kaynak Göster
Yıl 2023, Cilt: 9 Sayı: 3, 253 - 257, 30.09.2023

Öz

Proje Numarası

-

Kaynakça

  • [1] Kugelberg FC, Jones AW. (2007). Interpreting results of ethanol analysis in postmortem specimens: a review of the literature. Forensic Sci Int. 165(1):10-29. doi: 10.1016/j.forsciint.2006.05.004.
  • [2] Sjögren H, Eriksson A, Ahlm K. (2000) Role of alcohol in unnatural deaths: a study of all deaths in Sweden. Alcohol Clin Exp Res. doi:10.1111/j.1530-0277.2000.tb04649.x.
  • [3] NHTSA (National Highway Traffic Safety Administration), (2023, August 1) . Alcohol- and Drug-Impaired Driving https://www.nhtsa.gov/book/countermeasures/countermeasures-work/alcohol-and-drug-impaired-driving.
  • [4] WHO (World Health Organization), (2023, August 1) . Global status report on alcohol and health, 2018 https://www.who.int/publications/i/item/9789241565639.
  • [5] Fernie G, Christiansen P, Cole JC, Rose AK, Field M. (2012). Effects of 0.4 g/kg alcohol on attentional bias and alcohol-seeking behaviour in heavy and moderate social drinkers. J Psychopharmacol. 26(7):1017-25. doi: 10.1177/0269881111434621.
  • [6] Tiscione NB, Alford I, Yeatman DT, Shan X. (2011). Ethanol analysis by headspace gas chromatography with simultaneous flame-ionization and mass spectrometry detection. J Anal Toxicol. 35(7):501-11. doi: 10.1093/anatox/35.7.501. PMID: 21871160.
  • [7] Jones AW. (2000) Medicolegal alcohol determinations – breath- or blood alcohol concentrations?. Forensic Sci. Rev. 12:23–47.
  • [8]Traffic Law and Road Traffic Regulation No:6047, (2023, August 1) . Regulation Number:6047 https://www.mevzuat.gov.tr/mevzuatmetin/1.5.2918.pdf.
  • [9] Chun HJ, Poklis JL, Poklis A,Wolf CE. (2016). Development and validation of a method for alcohol analysis in brain tissue by headspace gas chromatography with flame ionization detector. Journal of Analytical Toxicology. 40: 653–658. doi: 10.1093/jat/bkw075.
  • [10] Snow NH, Slack GC. (2002). Head-space analysis in modern gas chromatography. Trends in Analytical Chemistry. 21(9–10): 608–617. doi: 10.1016/S0165-9936(02)00802-6.
  • [11] Nikelly JG, Betz JM (1987). Determination of ethanol in alcoholic beverages by liquid chromatography using the UV detector. Journal of Chromatographic Science. 25(9):391–394. https://doi.org/10.1093/chromsci/25.9.391.
  • [12] Yarita T, Nakajima R, Otsuka S, Ihara T, Takatsu A, Shibukawa M. (2002). Determination of ethanol in alcoholic beverages by high- performance liquid chromatography flame ionization detection using pure water as mobile phase. J Chromatogr AJ Chromatogr A. 976(1-2): 387–391. doi: 10.1016/S0021-9673(02)00942-1.
  • [13] Lachenmeier DW. (2007). Rapid quality control of spirit drinks and beer using multivariate data analysis of Fourier transform infrared spectra. Food Chemistry. 101(2): 825–832. doi: 10.1016/j.foodchem.2005.12.032.
  • [14] Hong-tao X, Lin H, Rong-Sheng T, Ji-Ying Y, Lu C, Jing Z et al. (2014). Rapid and Sensitive Headspace Gas Chromatography-Mass spectrometery Method for the analysis of Ethanol in the whole Blood. Journal of Clinical Laboratory Analysis. 28 (5): 386–390. doi: 10.1002/jcla.21698.
  • [15] O’Neal CL, Wolf CE, Levine B, Kunsman G, Poklis A. (1996). Gas chromatographic procedures for determination of ethanol in postmortemblood using t-butanol and methyl ethyl ketone as internal standards. Forensic Science International. 83(1) :31–38. doi: 1016/0379-0738(96)02007-5.
  • [16] De Martinis BS, Martins Ruzzene MA, Santos Martin CC. (2004). Determination of ethanol in human blood and urine by automated headspace solid-phase microextraction and capillary gas chromatography. Analytica Chimica Acta. 522(2):163–168. doi:10.1016/j.aca.2004.07.007.
  • [17] Zuba, D., Parczewski, A., & Reichenbcher, M. (2002). Optimization of solid-phase microextraction conditions for gas chromatographic determination of ethanol and other volatile compounds in blood. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences. 773(1):75–82. doi:10.1016/S1570-0232(02)00143-5.
  • [18] Diana D, Sorin M, Cornelia M, Elena B, Vasil A. (2009). Development and validation of a quantitative determination method of blood ethanol by gas chromatography with headspace (GC-HS). Romanian Journal of Legal Medicine. 17(4):303–308. doi: 10.4323/rjlm.2009.303.
  • [19] Peters FT, Maurer HH. (2002). Bioanalytical method validation and its implications for forensic and clinical toxicology – a review. Accredit. Qual. Assur. 7: 441–449. doi: 10.1007/s00769-002-0516-5.
  • [20] Scientific Working Group for Forensic Toxicology (SWGTOX). (2013). Standard practices for method validation in forensic toxicology. J. Anal.Toxicol. 37: 452-474. doi:10.1093/jat/bkt054.
  • [21] Matuszewski BK, Constanzer ML. (2003). Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC MS MS. Anal. Chem. 75: 3019–3030. doi:10.1021/ac020361s.
  • [22] ISO/IEC 17025:2017, (2017), (2023, August 1). General requirements for the competence of testing and calibration laboratories. https://www.iso.org/standard/66912.html.
  • [23] EURACHEM/CITAC,(2012), (2023, August 1). Quantifying Uncertainty in Analytical Measurement. https://www.eurachem.org/images/stories/Guides/pdf/QUAM2012_P1.pdf
  • [24] IHC (Harmonised Tripartite Guideline), (2005), (2023, August 1). International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use http://academy.gmp-compliance.org/guidemgr/files/ Q2(R1).pdf.
  • [25]Kristiansen J, Petersen HW. (2004). An uncertainty budget for the measurement of ethanol in blood by headspace gas chromatography. J Anal Toxicol. 28: 456-463. doi: 10.1093/jat/28.6.456.
  • [26]Sklerov JH, Couper FJ. (2011). Calculation and verification of blood ethanol measurement uncertainty for headspace gas chromatography. J Anal Toxicol. 35: 402-410. doi: 10.1093/anatox/ 35.7.402.
  • [27]Hwang RJ, Beltran J, Rogers C, Barlow J, Razatos G. (2017). Measurement of uncertainty for blood alcohol concentration by headspace gas chromatography. Can Soc Forensic Sci J. 50: 114-124. doi: 10.1111/1556-4029.13133.
  • [28]Zamengo L, Frison G, Tedeschi G, Frasson S, Zancanaro F, Sciarrone R. (2014). Variability of blood alcohol content (BAC) determinations: The role of measurement uncertainty, significant figures, and decision rules for compliance assessment in the frame of a multiple BAC threshold law. Drug Test Anal. 6: 1028-1037. doi: 10.1002/dta.1614.
  • [29] Prenesti, E, Bagnati, M, Berto, S, Basile, M, Vidali, M, Bellomo G. (2019). Measurement Uncertainty of Ethanol Concentration in Venous Whole Blood Determined By a HS GC MS Method. Analytical and Bioanalytical Techniques. 6:7. doi: 10.1080/23312009. 2020.1760187.

Method Validation and Measurement Uncertainty for the Determination of Ethanol in Whole Blood

Yıl 2023, Cilt: 9 Sayı: 3, 253 - 257, 30.09.2023

Öz

Alcohol intake is known to significantly affect driving ability and there is a relationship between Blood Alcohol Concentration (BAC) and the risk of road traffic accidents car accidents. Alcohol intake is known to significantly affect driving ability. Therefore, many countries define and monitor the legal BAC value for drivers. Customers or legal authorities require determining and reporting the measurement uncertainty in blood alcohol analysis from laboratories in recent years. In order to ensure the reliability and safety of the result, the method was validated and the measurement uncertainty was calculated. A rapid, selective and robust gas chromatography coupled with flame ionisation detection method was developed and validated for the quantitative determination of ethanol in whole blood. The method was validated for selectivity, matrix effect, recovery, and linearity, limit of detection (LOD), limit of quantification (LOQ), recovery, repeatability, reproducibility and robustness. The validation procedure was designed to be suitable for ISO 17025 accreditation. Uncertainty measurements were also determined for the validated method. LOD and LOQ were found 3.99 mg/dL and 4.30 mg/dL, respectively. The method showed good linearity in the range of 3.9 to 393.7 mg/dL ethanol with a correlation coefficient (r2 = 0.9999). The method provides fast, precise, simple, robust and unbiased results.

Destekleyen Kurum

-

Proje Numarası

-

Teşekkür

-

Kaynakça

  • [1] Kugelberg FC, Jones AW. (2007). Interpreting results of ethanol analysis in postmortem specimens: a review of the literature. Forensic Sci Int. 165(1):10-29. doi: 10.1016/j.forsciint.2006.05.004.
  • [2] Sjögren H, Eriksson A, Ahlm K. (2000) Role of alcohol in unnatural deaths: a study of all deaths in Sweden. Alcohol Clin Exp Res. doi:10.1111/j.1530-0277.2000.tb04649.x.
  • [3] NHTSA (National Highway Traffic Safety Administration), (2023, August 1) . Alcohol- and Drug-Impaired Driving https://www.nhtsa.gov/book/countermeasures/countermeasures-work/alcohol-and-drug-impaired-driving.
  • [4] WHO (World Health Organization), (2023, August 1) . Global status report on alcohol and health, 2018 https://www.who.int/publications/i/item/9789241565639.
  • [5] Fernie G, Christiansen P, Cole JC, Rose AK, Field M. (2012). Effects of 0.4 g/kg alcohol on attentional bias and alcohol-seeking behaviour in heavy and moderate social drinkers. J Psychopharmacol. 26(7):1017-25. doi: 10.1177/0269881111434621.
  • [6] Tiscione NB, Alford I, Yeatman DT, Shan X. (2011). Ethanol analysis by headspace gas chromatography with simultaneous flame-ionization and mass spectrometry detection. J Anal Toxicol. 35(7):501-11. doi: 10.1093/anatox/35.7.501. PMID: 21871160.
  • [7] Jones AW. (2000) Medicolegal alcohol determinations – breath- or blood alcohol concentrations?. Forensic Sci. Rev. 12:23–47.
  • [8]Traffic Law and Road Traffic Regulation No:6047, (2023, August 1) . Regulation Number:6047 https://www.mevzuat.gov.tr/mevzuatmetin/1.5.2918.pdf.
  • [9] Chun HJ, Poklis JL, Poklis A,Wolf CE. (2016). Development and validation of a method for alcohol analysis in brain tissue by headspace gas chromatography with flame ionization detector. Journal of Analytical Toxicology. 40: 653–658. doi: 10.1093/jat/bkw075.
  • [10] Snow NH, Slack GC. (2002). Head-space analysis in modern gas chromatography. Trends in Analytical Chemistry. 21(9–10): 608–617. doi: 10.1016/S0165-9936(02)00802-6.
  • [11] Nikelly JG, Betz JM (1987). Determination of ethanol in alcoholic beverages by liquid chromatography using the UV detector. Journal of Chromatographic Science. 25(9):391–394. https://doi.org/10.1093/chromsci/25.9.391.
  • [12] Yarita T, Nakajima R, Otsuka S, Ihara T, Takatsu A, Shibukawa M. (2002). Determination of ethanol in alcoholic beverages by high- performance liquid chromatography flame ionization detection using pure water as mobile phase. J Chromatogr AJ Chromatogr A. 976(1-2): 387–391. doi: 10.1016/S0021-9673(02)00942-1.
  • [13] Lachenmeier DW. (2007). Rapid quality control of spirit drinks and beer using multivariate data analysis of Fourier transform infrared spectra. Food Chemistry. 101(2): 825–832. doi: 10.1016/j.foodchem.2005.12.032.
  • [14] Hong-tao X, Lin H, Rong-Sheng T, Ji-Ying Y, Lu C, Jing Z et al. (2014). Rapid and Sensitive Headspace Gas Chromatography-Mass spectrometery Method for the analysis of Ethanol in the whole Blood. Journal of Clinical Laboratory Analysis. 28 (5): 386–390. doi: 10.1002/jcla.21698.
  • [15] O’Neal CL, Wolf CE, Levine B, Kunsman G, Poklis A. (1996). Gas chromatographic procedures for determination of ethanol in postmortemblood using t-butanol and methyl ethyl ketone as internal standards. Forensic Science International. 83(1) :31–38. doi: 1016/0379-0738(96)02007-5.
  • [16] De Martinis BS, Martins Ruzzene MA, Santos Martin CC. (2004). Determination of ethanol in human blood and urine by automated headspace solid-phase microextraction and capillary gas chromatography. Analytica Chimica Acta. 522(2):163–168. doi:10.1016/j.aca.2004.07.007.
  • [17] Zuba, D., Parczewski, A., & Reichenbcher, M. (2002). Optimization of solid-phase microextraction conditions for gas chromatographic determination of ethanol and other volatile compounds in blood. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences. 773(1):75–82. doi:10.1016/S1570-0232(02)00143-5.
  • [18] Diana D, Sorin M, Cornelia M, Elena B, Vasil A. (2009). Development and validation of a quantitative determination method of blood ethanol by gas chromatography with headspace (GC-HS). Romanian Journal of Legal Medicine. 17(4):303–308. doi: 10.4323/rjlm.2009.303.
  • [19] Peters FT, Maurer HH. (2002). Bioanalytical method validation and its implications for forensic and clinical toxicology – a review. Accredit. Qual. Assur. 7: 441–449. doi: 10.1007/s00769-002-0516-5.
  • [20] Scientific Working Group for Forensic Toxicology (SWGTOX). (2013). Standard practices for method validation in forensic toxicology. J. Anal.Toxicol. 37: 452-474. doi:10.1093/jat/bkt054.
  • [21] Matuszewski BK, Constanzer ML. (2003). Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC MS MS. Anal. Chem. 75: 3019–3030. doi:10.1021/ac020361s.
  • [22] ISO/IEC 17025:2017, (2017), (2023, August 1). General requirements for the competence of testing and calibration laboratories. https://www.iso.org/standard/66912.html.
  • [23] EURACHEM/CITAC,(2012), (2023, August 1). Quantifying Uncertainty in Analytical Measurement. https://www.eurachem.org/images/stories/Guides/pdf/QUAM2012_P1.pdf
  • [24] IHC (Harmonised Tripartite Guideline), (2005), (2023, August 1). International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use http://academy.gmp-compliance.org/guidemgr/files/ Q2(R1).pdf.
  • [25]Kristiansen J, Petersen HW. (2004). An uncertainty budget for the measurement of ethanol in blood by headspace gas chromatography. J Anal Toxicol. 28: 456-463. doi: 10.1093/jat/28.6.456.
  • [26]Sklerov JH, Couper FJ. (2011). Calculation and verification of blood ethanol measurement uncertainty for headspace gas chromatography. J Anal Toxicol. 35: 402-410. doi: 10.1093/anatox/ 35.7.402.
  • [27]Hwang RJ, Beltran J, Rogers C, Barlow J, Razatos G. (2017). Measurement of uncertainty for blood alcohol concentration by headspace gas chromatography. Can Soc Forensic Sci J. 50: 114-124. doi: 10.1111/1556-4029.13133.
  • [28]Zamengo L, Frison G, Tedeschi G, Frasson S, Zancanaro F, Sciarrone R. (2014). Variability of blood alcohol content (BAC) determinations: The role of measurement uncertainty, significant figures, and decision rules for compliance assessment in the frame of a multiple BAC threshold law. Drug Test Anal. 6: 1028-1037. doi: 10.1002/dta.1614.
  • [29] Prenesti, E, Bagnati, M, Berto, S, Basile, M, Vidali, M, Bellomo G. (2019). Measurement Uncertainty of Ethanol Concentration in Venous Whole Blood Determined By a HS GC MS Method. Analytical and Bioanalytical Techniques. 6:7. doi: 10.1080/23312009. 2020.1760187.
Toplam 29 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Cerrahi (Diğer)
Bölüm Araştırma Makalesi
Yazarlar

Yeter Erol Öztürk 0000-0001-9503-7057

Proje Numarası -
Erken Görünüm Tarihi 7 Eylül 2023
Yayımlanma Tarihi 30 Eylül 2023
Gönderilme Tarihi 17 Ağustos 2023
Kabul Tarihi 7 Eylül 2023
Yayımlandığı Sayı Yıl 2023 Cilt: 9 Sayı: 3

Kaynak Göster

APA Erol Öztürk, Y. (2023). Method Validation and Measurement Uncertainty for the Determination of Ethanol in Whole Blood. International Journal of Computational and Experimental Science and Engineering, 9(3), 253-257.