Analytical Method Validation in Forensic Assay

Yıl 2020, Cilt: 2 Sayı: 1, 9 - 24, 11.09.2020

Burcu Doğan Topal , İrem Kaya Sibel A. Özkan

Öz

Reliable analytical data is an essential requisite for accurate interpretation
of toxicological findings in the forensic science. If the analytical
data is not reliable, it may lead to wrong legal processes for the defendant
or the wrong treatment of the patient. Therefore, analytical methods
to be used in forensic science require careful method development and
validation. Method validation is the most important and key element in
establishing reference methods and evaluating the ability of a laboratory to
produce reliable analytical data. Newly developed or routine used analytical
methods must validate according to the standard guidelines. Analytical
method validation should include several performance factors such as: Selectivity,
specificity, accuracy, precision, linearity, range, limit of detection
(LOD), limit of quantification (LOQ), stability, ruggedness, and robustness
etc.

Anahtar Kelimeler

Analytical methods, forensic science, criminal analysis, validation, determination, performance characteristics

Adli Analizde Analitik Yöntem Doğrulaması

Öz

Adli bilimlerde toksikolojik bulguların doğru yorumlanması için güvenilir analitik verilere ihtiyaç vardır. Analitik veri güvenilir değilse, bu, sanık için yanlış hukuki süreçlere veya hastanın yanlış tedavisine yol açabilir. Bu nedenle, adli bilimlerde kullanılacak analitik yöntemlerin dikkatli bir şekilde yöntem geliştirilmesi ve doğrulanması gerekmektedir. Yöntem doğrulaması, referans yöntemlerinin oluşturulmasında ve bir laboratuvarın güvenilir analitik veri üretebilme yeteneğinin değerlendirilmesinde en önemli ve anahtar unsurdur. Yeni geliştirilmiş veya rutin olarak kullanılan analitik yöntemler, standart rehberlere göre doğrulanmalıdır. Analitik yöntem doğrulaması, seçicilik, özgüllük, doğruluk, hassasiyet, doğrusallık, aralık, tespit sınırı (LOD), nicelleme sınırı (LOQ), stabilite, sağlamlık ve robustluk gibi birkaç performans faktörünü içermelidir.

Anahtar Kelimeler

Analitik Yöntemler, Adli Bilimler, Suç Analizi, Doğrulama, Belirleme, Performans Özellikleri

Kaynakça

• Barnett, K.L., Harrington, B. ve Graul, T.W. (2013). Validation of liquid chromatographic methods. Hollanda: Elsevier.
• Barron, L., Gilchrist, E. (2014). Ion chromatography-mass spectrometry: A review of recent technologies and applications ın forensic and environmental explosives analysis. Analytica Chimica Acta. C. 806, ss. 27-54.
• Blessy, M. R. D. P., Patel, R. D., Prajapati, P. N. ve Agrawal, Y. K. (2014). Development of forced degradation and stability ındicating studies of drugs-a review. Journal of Pharmaceutical Analysis. C. 4, S. 3, ss. 159-165.
• Burleson, G. L., Gonzalez, B., Simons, K. ve Jorn, C. C. (2009). Forensic analysis of a single particle of partially burnt gunpowder by solid phase micro-extraction-gas chromatography-nitrogen phosphorus detector. Journal of Chromatography A. C. 1216, S. 22, ss. 4679-4683.
• Chophi, R., Sharma, S., Sharma, S. ve Singh, R. (2019). Trends in the forensic analysis of cosmetic evidence. Forensic Chemistry. C. 14.
• Dogan-Topal, B., Li, W., Schinkel, A. H., Beijnen, J. H. ve Sparidans, R. W. (2019). Quantification of FGFR4 inhibitor BLU-554 in mouse plasma and tissue homogenates using liquid chromatography-tandem mass spectrometry. Journal of Chromatography B. C. 1110, ss. 116-123.
• Emniyet Genel Müdürlüğü Kriminal Daire Başkanlığı. (2019). Kimya. https://www.egm. gov.tr/kriminal/kimyauzmanlik. (E.T.: 16 Aralık 2019).
• Encylcopedia Britannica. (2019). Crime laboratory. https://www.britannica.com/ science/crime-laboratory#ref310184 ve https://www.britannica.com/science/crimelaboratory# ref310184. (E.T.: 16 Aralık 2019).
• Ermer, J., John, H. ve Miller, M. (2005). Method validation in pharmaceutical analysis. Weinheim.
• European Medicines Agency. (2003). Ich topic q 1 a (r2) stability testing of new drug substances and products step, ıch-stability test. New drug subst. Prod. 1–20. doi:10.1136/bmj.333.7574.873-a.
• Gallidabino, M. D., Irlam, R. C., Salt, M. C., O’Donnell, M., Beardah, M. S. ve Barron, L. P. (2019). Targeted and non-targeted forensic profiling of black powder substitutes and gunshot residue using gradient ıon chromatography-high resolution mass spectrometry (ıc-hrms). Analytica Chimica Acta. C. 1072, ss. 1-14. General Chapters: <1225> Validation of compendial methods, (n.d.).
• González, O., Alonso, R. M. (2020). Validation of bioanalytical chromatographic methods for the quantification of drugs in biological fluids. In Handbook of Analytical Separations. C. 7, ss. 115-134.
• Grapp, M., Kaufmann, C.,Streit, F. ve Binder, L. (2018). Systematic forensic toxicological analysis by liquid-chromatography-quadrupole-time-of-flight mass spectrometry ın serum and comparison to gas chromatography-mass spectrometry, Forensic Science International. C. 287, ss. 63-73.
• Gruber, B., Weggler, B. A., Jaramillo, R., Murrell, K. A., Piotrowski, P. K. ve Dorman, F. L. (2018). Comprehensive two-dimensional gas chromatography in forensic science: A critical review of recent trends. TrAC Trends In Analytical Chemistry. C. 105, ss. 292-301.
• Junior, V. G., Hazarbassanov, N. Q., de Siqueira, A., Florio, J. C., Ciscato, C. H. P., Maiorka, P. C. ve De Souza Spinosa, H. (2017). Development and validation of carbofuran and 3-hydroxycarbofuran analysis by high-pressure liquid chromatography with diode array detector (hplc-dad) for forensic veterinary medicine. Journal of Chromatography B. C. 1065, ss.8-13.
• Krull, I. S., Swartz, M. (1999). Analytical method development and validation for the academic researcher. Analytical Letters. C. 32, ss. 1067- 1080.
• Majda, A., Mrochem, K., Wietecha-Posłuszny, R., Zapotoczny, S. ve Zawadzki, M. (2020). Fast and efficient analyses of the post-mortem human blood and bone marrow using dı- SPME/LC-TOFMS method for forensic medicine purposes. Talanta. C. 209.
• Morgan, R. M. (2017). Conceptualising forensic science and forensic reconstruction. Part I: A conceptual model. Science & Justice. C. 57, S. 6, ss. 455-459.
• Murrie, D. C., Gardner, B. O., Kelley, S. ve Dror, I. E. (2019). Perceptions and estimates of error rates in forensic science: a survey of forensic analysts. Forensic Science International. C. 302.
• Mustafiz, S., Dupont, G., Khendek, F. ve Toeroe, M. (2018). MAPLE: An integrated environment for process modelling and enactment for NFV systems. In European Conference on Modelling Foundations and Applications. ss. 164-178. N. Academy, N.A.S. Report, T.N.A.S. Report, T.I. Standard, A. Board, A. Program, T.
• Dna, A. Board, Q. Assurance, F. Dna, T. Laboratories, Validation of Forensic Science Techniques. (2009).
• Ozkan, S. A., Kauffmann, J. M. ve Zuman, P. (2015). Electroanalysis in biomedical and pharmaceutical sciences: Voltammetry, amperometry, biosensors, applications. Springer. Belçika.
• Ozkan, S.A., Kauffmann, J.-M. ve Zuman, P. (2015). Electroanalytical method validationmethod validation in pharmaceutical analysis and their applications. Belçika.
• Peters, F. T. ve Maurer, H. H. (2002). Bioanalytical method validation and ıts ımplications for forensic and clinical toxicology-a review. Validation In Chemical Measurement. ss 1-9. Q2B Validation of Analytical Procedures: Methodology | FDA, (n.d.).
• Rawtani, D., Tharmavaram, M., Pandey, G., & Hussain, C. M. (2019). Functionalized nanomaterial for forensic sample analysis. TrAC Trends in Analytical Chemistry. C. 120.
• Reichenbächer, M., Einax, J. W. (2011). Challenges in analytical quality assurance. Springer Science & Business Media. Almanya. Riley, C.M., Rosanske, T.W. (1996). Development and validation of analytical methods. New York.
• Rivier, L. (2003). Criteria for the identification of compounds by liquid chromatographymass spectrometry and liquid chromatography-multiple mass spectrometry ın forensic toxicology and doping analysis. Analytica Chimica Acta. C. 492, S. 1-2, ss. 69-82.
• Roux, C., Crispino, F. ve Ribaux, O. (2012). From forensics to forensic science. Current Issues in Criminal Justice. C. 24, S. 1, ss. 7-24.
• Singh, S., Junwal, M., Modhe, G., Tiwari, H., Kurmi, M., Parashar, N. ve Sidduri, P. (2013). Forced degradation studies to assess the stability of drugs and products. TrAC Trends in Analytical Chemistry. C. 49, ss. 71-88.
• Taylor, J. K. (1983). Validation of analytical methods. Analytical chemistry. Analytical Chemistry. C. 55, S. 6, ss. 600A-608A.
• Terada, M., Shinozuka, T., Hasegawa, C., Tanaka, E., Hayashida, M., Ohno, Y. ve Kurosaki, K. (2013). Analysis of quazepam and its metabolites in human urine by gas chromatography-mass spectrometry: application to a forensic case. Forensic Science International. C. 227, S. 1-3, ss. 95-99.
• United Nations Office on Drugs and Crime. (2009). A commitment to quality and continuous ımprovement.
• Verplaetse, R. ve Tytgat, J. (2012). Development and validation of a sensitive uplc–ms/ ms method for the analysis of narcotic analgesics ın urine and whole blood in forensic context. Forensic Science International. C. 215, S. 1-3, ss. 136-145.
• Xu, X., Koeberg, M., Kuijpers, C. J. ve Kok, E. (2014). Development and validation of highly selective screening and confirmatory methods for the qualitative forensic analysis of organic explosive compounds with high performance liquid chromatography coupled with (photodiode array and) LTQ ion trap/orbitrap mass spectrometric detections (HPLC-(PDA)-ltqorbitrap). Science & justice. C. 54, S. 1, ss. 3-21.
• Zhou, D., Porter, W. R. ve Zhang, G. G. (2009). Drug stability and degradation studies. In developing solid oral dosage forms. Academic Press. ss. 87-124.