DOI: https://doi.org/10.24959/nphj.17.2191

Development of the UV-spectrophotometric and extraction-spectrophotometric methods of the atomoxetine quantitative determination suitable for the chemical and toxicological analysis

L. Yu. Tomarovska, S. V. Baiurka, S. A. Karpushyna

Abstract


The acute and lethal antidepressant poisonings have the tendency to grow, therefore, development of the methods for its chemical and toxicological analysis is a topical issue.

Aim. To develop and validate the methods for the quantitative determination of atomoxetine, an antidepressant, using available and widely spread methods in the chemical and toxicological analysis practice, such as UV spectrophotometry and extraction-spectrophotometry in the visible region of the spectrum with methyl orange, an acidic azo dye.

Materials and methods. Absorbance values of the solutions in the UV and visible regions of the spectrum were measured on a SF-46 spectrophotometer (LOMO), the spectral measurement range was from 190 to 1100 nm. The standard solution of atomoxetine in 0.1 M hydrocloric acid (300 μg/ml) was used for the UV spectrophotometric study, and the standard solution of atomoxetine in water (150 μg/ml) was used for the extraction spectrophotometry in the visible region.

Results and discussion. The calibration curve for the UV spectrophotometric method was described by the equation of y = (0.00455 ± 4 · 10-5)x + (0.016 ± 0.005); linearity was observed within the atomoxetine concentration range of 15.0-210 μg/ml; LOD and LOQ were 1.8 μg/ml and 5.6 μg/ml, respectively. The calibration curve for the extraction spectrophotometric method was described by the equation of y = (0.00808 ± 5 · 10-5)x; linearity was observed within the atomoxetine concentrations of 15.0-150.0 μg in a sample; LOD and LOQ were 1.4 μg and 4.3 μg in a sample, respectively.

Conclusions. The methods developed for the quantitative determination of atomoxetine using the UV-spectrophotometric method and extraction spectrophotometry in the visible region of the spectrum satisfy the requirements set to the methods recommended for use in the forensic toxicology, and it has been confirmed by the validation characteristics.


Keywords


atomoxetine; UV-spectrophotometry; extraction spectrophotometry in the visible region of the spectrum

Full Text:

PDF

References


Treuer, T., Gau, S. S.–F., Méndez, L., Montgomery, W., Monk, J. A., Altin, M., Dueñas, H. J. (2013). A Systematic Review of Combination Therapy with Stimulants and Atomoxetine for Attention–Deficit/Hyperactivity Disorder, Including Patient Characteristics, Treatment Strategies, Effectiveness, and Tolerability. Journal of Child and Adolescent Psychopharmacology, 23 (3), 179–193. doi: 10.1089/cap.2012.0093

Paxton, G. A., Cranswick, N. E. (2008). Acute suicidality after commencing atomoxetine. Journal of Paediatrics and Child Health, 44 (10), 596–598. doi: 10.1111/j.1440–1754.2008.01389.x

Garside, D., Ropero–Miller, J. D., Riemer, E. C. (2006). Postmortem Tissue Distribution of Atomoxetine Following Fatal and Nonfatal Doses–Three Case Reports. Journal of Forensic Sciences, 51 (1), 179–182. doi: 10.1111/j.1556–4029.2005.00021.x

Moffat, A. C., Osselton, M. D., Widdop B., Clarke, E. G. C. (2011). Clarke’s analysis of drugs and poisons in pharmaceuticals, body fluids and postmortem material, (4–th ed.). London, Chicago : Pharmaceutical Press, 2736.

Patel, C., Patel, M., Rani, S., Nivsarkar, M., Padh, H. (2007). A new high performance liquid chromatographic method for quantification of atomoxetine in human plasma and its application for pharmacokinetic study. Journal of Chromatography B, 850 (1–2), 356–360. doi: 10.1016/j.jchromb.2006.12.011

Guo, W., Li, W., Guo, G., Zhang, J., Zhou, B., Zhai, Y., Wang, C. (2007). Determination of atomoxetine in human plasma by a high performance liquid chromatographic method with ultraviolet detection using liquid–liquid extraction. Journal of Chromatography B, 854 (1–2), 128–134. doi: 10.1016/j.jchromb.2007.04.007

Zhu, H.–J., Wang, J.–S., Donovan, J. L., DeVane, C. L., Gibson, B. B., Markowitz, J. S. (2007). Sensitive quantification of atomoxetine in human plasma by HPLC with fluorescence detection using 4–(4,5–diphenyl–1H–imidazole–2–yl) benzoyl chloride derivatization. Journal of Chromatography B, 846 (1–2), 351–354. doi: 10.1016/j.jchromb.2006.08.019

Appel, D. I., Brinda, B., Markowitz, J. S., Newcorn, J. H., Zhu, H.–J. (2012). A liquid chromatography/tandem mass spectrometry assay for the analysis of atomoxetine in human plasma andin vitrocellular samples. Biomedical Chromatography, 26 (11), 1364–1370. doi: 10.1002/bmc.2706

Zeng, H., Yang, R., Zhang, Y., Li, J., Qu, L. (2014). Capillary electrophoresis coupled with electrochemiluminescence for determination of atomoxetine hydrochloride and the study on its interactions with three proteins. Luminescence, 30 (2), 124–130. doi: 10.1002/bio.2700

Jickells, S., Negrusz, A. (2008). Clarke’s Analytical Forensic Toxicology. London : Pharmaceutical Press. 648.

Vergeichik, T. Kh. (2009). Toksikologicheskaia khimiia. Moscow : MEDpress–inform, 400.

12. Guidance for the Validation of Analytical Methodology and Calibration of Equipment used for Testing of Illicit Drugs in Seized Materials and Biological Specimens. (2009). New York : United Nations Office on Drugs and Crime (Vienna), 67.

Tomarovska, L. Y., Baiurka, S. V., Karpushyna, S. A. (2017). Development of the methods for atomoxetine identification suitable for the chemical and toxicological analysis. Vìsnik Farmacìï, 2 (90), 13–20. doi: 10.24959/nphj.17.2154

Bolotov, V. V., Sviechnikova, O. M., Kolisnyk, S. V., Zhukova, T. V., Sych, Yu. V., Dynnyk, K. V., Zarechenskyi, M. A., Mykytenko, O. Ye., Hryzodub, O. I., Terno, I. S. (2004). Analitychna khimiia. Kharkiv: NUPh, 480.

15. Derzhavna Farmakopeia Ukrainy, 1-st ed. (2008). Kharkiv: Naukovo–ekspertnyi farmakopeinyi tsentr, 620.

16. SOFT/AAFS Forensic Laboratory Guidelines. (2006). Available at: http://www.soft–tox.org/files/Guidelines_2006_Final.pdf


GOST Style Citations


1.         A systematic review of combination therapy with stimulants and atomoxetine for attention–deficit/hyperactivity disorder, including patient characteristics, treatment strategies, effectiveness, and tolerability / T. Treuer, S. S. Gau, L. Méndez et al. // J. Child Adolesc. Psychopharmacol. – 2013. – Vol. 23, Issue 3. – P. 179–193. doi: 10.1089/cap.2012.0093

2.         Paxton, G. A. Acute suicidality after commencing atomoxetine / G. A. Paxton, N. E Cranswick // J. Paediatr. Child Health. – 2008. – Vol. 44, Issue 10. – P. 596–598. doi: 10.1111/j.1440–1754.2008.01389.x

3.         Garside, D. Postmortem tissue distribution of atomoxetine following fatal and nonfatal doses – three case reports / D. Garside, J. D. Ropero–Miller, E. C. Riemer // J. Forensic Sci. – 2006. – Vol. 51, Issue 1. – P. 179–182. doi: 10.1111/j.1556–4029.2005.00021.x

4.         Clarke’s analysis of drugs and poisons in pharmaceuticals, body fluids and postmortem material : 4–th ed. / ed. by A. C. Moffat, M. D. Osselton, B. Widdop. – London, Chicago : Pharmaceutical Press, 2011. – 2736 p.

5.         A new high performance liquid chromatographic method for quantification of atomoxetine in human plasma and its application for pharmacokinetic study / C. Patel, M. Patel, S. Rani et al. // J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. – 2007. – Vol. 850, Issue 1–2. – P. 356–360. doi: 10.1016/j.jchromb.2006.12.011

6.         Determination of atomoxetine in human plasma by a high performance liquid chromatographic method with ultraviolet detection using liquid–liquid extraction / W. Guo, W. Li, G. Guo et al. // J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. – 2007. – Vol. 854, Issue 1–2. – P. 128–134. doi: 10.1016/j.jchromb.2007.04.007

7.         Sensitive quantification of atomoxetine in human plasma by HPLC with fluorescence detection using 4–(4,5–diphenyl–1H–imidazole–2–yl) benzoyl chloride derivatization / H. J. Zhu, J. S. Wang, J. L. Donovan et al. // J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. – 2007. – Vol. 846, Issue 1–2. – P. 351–354. doi: 10.1016/j.jchromb.2006.08.019

8.         A liquid chromatography/tandem mass spectrometry assay for the analysis of atomoxetine in human plasma and in vitro cellular samples / D. I. Appel, B. Brinda, J. S. Markowitz et al. // Biomed. Chromatogr. – 2012. – Vol. 26, Issue 11. – P. 1364–1370. doi: 10.1002/bmc.2706

9.         Capillary electrophoresis coupled with electrochemiluminescence for determination of atomoxetine hydrochloride and the study on its interactions with three proteins / H. J. Zeng, R. Yang, Y. Zhang et al. // Luminescence. – 2014. – Vol. 30, Issue 2. – P. 124–130. doi: 10.1002/bio.2700

10.       Clarke’s Analytical Forensic Toxicology / ed. by Sue Jickells, Adam Negrusz. – London : Pharmaceutical Press, 2008. – 648 p.

11.       Вергейчик, Т. Х. Токсикологическая химия / Т. Х. Вергейчик. – М. : МЕДпресс–информ, 2009. – 400 с.

12.       Guidance for the Validation of Analytical Methodology and Calibration of Equipment used for Testing of Illicit Drugs in Seized Materials and Biological Specimens / United Nations Office on Drugs and Crime (Vienna). – New York, 2009. – 67 p.

13.       Tomarovska, L. Yu. Development of the methods for atomoxetine identification suitable for the chemical and toxicological analysis / L. Yu. Tomarovska, S. V. Baiurka, S. A. Karpushyna // Вісник фармації. – 2017. – № 2 (90). – С. 13–20. doi: 10.24959/nphj.17.2154.

14.       Аналітична хімія : навч. посіб. для фармац. ВНЗ та ф–тів ІІІ–IV рівнів акредитації / В. В. Болотов, О. М. Свєчнікова, С. В. Колісник та ін. – Х. : НФаУ, 2004. – 480 с.

15.       Державна фармакопея України. Доп. 2. / Державне підприємство «Науково–експертний фармакопейний центр». – 1–е вид. – Х. : Науково–експертний фармакопейний центр, 2008. – 620 с.

16.       SOFT / AAFS Forensic Laboratory Guidelines. – 2006. – 24 p. – [Электронный ресурс]. – Available at : http://www.soft–tox.org/files/Guidelines_2006_Final.pdf





Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.

Abbreviated key title: Vìsn. farm.

ISSN 2415-8844 (Online), ISSN 1562-7241 (Print)