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Yıl 2025, Cilt: 5 Sayı: 1, 22 - 27, 25.06.2025

Bilal Yılmaz , Emrah Alkan

https://doi.org/10.5281/zenodo.15729141

Öz

Kaynakça

  • 1. Gibson TP. Pharmacokinetics, efficacy, and safety of analgesia with a focus on tramadol HCl. Am J Med. 1996;101:S47-S53. doi:10.1016/S0002-9343(96)00138-6
  • 2. Shipton EA. Tramadol—Present and Future. Anaesth Intensive Care. 2000;28(4):363-374. doi:10.1177/0310057X0002800403
  • 3. Cooper RJ. Over-the-counter medicine abuse – a review of the literature. J Subst Use. 2013;18(2):82-107. doi:10.3109/14659891.2011.615002
  • 4. Almér Herrnsdorf E, Holmstedt A, Håkansson A. Tramadol misuse in treatment-seeking adolescents and young adults with problematic substance use – Prediction of treatment retention. Addict Behav Reports. 2022;16:100446. doi:10.1016/j.abrep.2022.100446
  • 5. Miotto K, Cho AK, Khalil MA, Blanco K, Sasaki JD, Rawson R. Trends in Tramadol: Pharmacology, Metabolism, and Misuse. Anesth Analg. 2017;124(1):44-51. doi:10.1213/ANE.0000000000001683
  • 6. Allegaert K, Anderson BJ, Verbesselt R, et al. Tramadol disposition in the very young: an attempt to assess in vivo cytochrome P -450 2D6 activity. Br J Anaesth. 2005;95(2):231-239. doi:10.1093/bja/aei170
  • 7. Goeringer KE, Logan BK, Christian GD. Identification of Tramadol and its Metabolites in Blood from Drug-Related Deaths and Drug-Impaired Drivers. J Anal Toxicol. 1997;21(7):529-537. doi:10.1093/jat/21.7.529
  • 8. Quetglas EG, Azanza JR, Cardenas E, Sádaba B, Campanero MA. Stereoselective pharmacokinetic analysis of tramadol and its main phase I metabolites in healthy subjects after intravenous and oral administration of racemic tramadol. Biopharm Drug Dispos. 2007;28(1):19-33. doi:10.1002/bdd.526
  • 9. Ardakani YH, Rouini M. Pharmacokinetics of tramadol and its three main metabolites in healthy male and female volunteers. Biopharm Drug Dispos. 2007;28(9):527-534. doi:10.1002/bdd.584
  • 10. El-Sayed A-AY, Mohamed KM, Nasser AY, Button J, Holt DW. Simultaneous determination of tramadol, O-desmethyltramadol and N-desmethyltramadol in human urine by gas chromatography–mass spectrometry. J Chromatogr B. 2013;926:9-15. doi:10.1016/j.jchromb.2013.02.019
  • 11. Ghasemi E. Optimization of solvent bar microextraction combined with gas chromatography mass spectrometry for preconcentration and determination of tramadol in biological samples. J Chromatogr A. 2012;1251:48-53. doi:10.1016/j.chroma.2012.06.060
  • 12. Sha YF, Shen S, Duan GL. Rapid determination of tramadol in human plasma by headspace solid-phase microextraction and capillary gas chromatography–mass spectrometry. J Pharm Biomed Anal. 2005;37(1):143-147. doi:10.1016/j.jpba.2004.09.050
  • 13. Rudaz S, Veuthey JL, Desiderio C, Fanali S. Simultaneous stereoselective analysis by capillary electrophoresis of tramadol enantiomers and their main phase I metabolites in urine. J Chromatogr A. 1999;846(1-2):227-237. doi:10.1016/S0021-9673(99)00028-X
  • 14. Valle M, Pavón J., Calvo R, Campanero M., Trocóniz I. Simultaneous determination of tramadol and its major active metabolite O-demethyltramadol by high-performance liquid chromatography with electrochemical detection. J Chromatogr B Biomed Sci Appl. 1999;724(1):83-89. doi:10.1016/S0378-4347(98)00547-7
  • 15. Ceccato A, Vanderbist F, Pabst J-Y, Streel B. Enantiomeric determination of tramadol and its main metabolite O-desmethyltramadol in human plasma by liquid chromatography–tandem mass spectrometry. J Chromatogr B Biomed Sci Appl. 2000;748(1):65-76. doi:10.1016/S0378-4347(00)00318-2
  • 16. Musshoff F, Madea B, Stuber F, Stamer UM. Enantiomeric Determination of Tramadol and O-Desmethyltramadol by Liquid Chromatography-Mass Spectrometry and Application to Postoperative Patients Receiving Tramadol. J Anal Toxicol. 2006;30(7):463-467. doi:10.1093/jat/30.7.463
  • 17. Musshoff F, Trafkowski J, Kuepper U, Madea B. An automated and fully validated LC‐MS/MS procedure for the simultaneous determination of 11 opioids used in palliative care, with 5 of their metabolites. J Mass Spectrom. 2006;41(5):633-640. doi:10.1002/jms.1021
  • 18. Zhu T, Ding L, Guo X, Yang L, Wen A. Simultaneous Determination of Tramadol and Acetaminophen in Human Plasma by LC–ESI–MS. Chromatographia. 2007;66(3-4):171-178. doi:10.1365/s10337-007-0268-9
  • 19. Campanero MA, Calahorra B, García-Quetglás E, Escolar M, Honorato J. High-performance liquid chromatographic assay for simultaneous determination of tramadol and its active metabolite in human plasma. Application to pharmacokinetic studies. Chromatographia. 1998;48(7-8):555-560. doi:10.1007/BF02466649
  • 20. Nobilis M, Kopecký J, Květina J, et al. High-performance liquid chromatographic determination of tramadol and its O-desmethylated metabolite in blood plasma. J Chromatogr A. 2002;949(1-2):11-22. doi:10.1016/S0021-9673(01)01567-9
  • 21. Campanero MA, Garcı́a-Quetglas E, Sádaba B, Azanza JR. Simultaneous stereoselective analysis of tramadol and its primary phase I metabolites in plasma by liquid chromatography. J Chromatogr A. 2004;1031(1-2):219-228. doi:10.1016/j.chroma.2003.11.034
  • 22. Pedersen RS, Brøsen K, Nielsen F. Enantioselective HPLC method for quantitative determination of tramadol andO-desmethyltramadol in plasma and urine: Application to clinical studies. Chromatographia. 2003;57(5-6):279-285. doi:10.1007/BF02492397
  • 23. Rouini M-R, Ardakani YH, Soltani F, Aboul-Enein HY, Foroumadi A. Development and validation of a rapid HPLC method for simultaneous determination of tramadol, and its two main metabolites in human plasma. J Chromatogr B. 2006;830(2):207-211. doi:10.1016/j.jchromb.2005.10.039
  • 24. LI Q, Wang R. Simultaneous analysis of tramadol, metoprolol and their metabolites in human plasma and urine by high performance liquid chromatography. Chin Med J (Engl). 2006;119(23). https://journals.lww.com/cmj/fulltext/2006/12010/simultaneous_analysis_of_tramadol,_metoprolol_and.12.aspx
  • 25. Validation of analytical procedures: Text and Methodology. In: International Conference on Harmonization (ICH). Commission of the European Communities. Vol 2. ; 1996.
  • 26. Gan S., Ismail R. Validation of a high-performance liquid chromatography method for tramadol and o-desmethyltramadol in human plasma using solid-phase extraction. J Chromatogr B Biomed Sci Appl. 2001;759(2):325-335. doi:10.1016/S0378-4347(01)00237-7
  • 27. Ardakani YH, Rouini M-R. Improved liquid chromatographic method for the simultaneous determination of tramadol and its three main metabolites in human plasma, urine and saliva. J Pharm Biomed Anal. 2007;44(5):1168-1173. doi:10.1016/j.jpba.2007.04.012
  • 28. Moore C, Rana S, Coulter C. Determination of meperidine, tramadol and oxycodone in human oral fluid using solid phase extraction and gas chromatography–mass spectrometry. J Chromatogr B. 2007;850(1-2):370-375. doi:10.1016/j.jchromb.2006.12.008
  • 29. Cheng P-S, Lee C-H, Liu C, Chien C-S. Simultaneous Determination of Ketamine, Tramadol, Methadone, and their Metabolites in Urine by Gas Chromatography-Mass Spectrometry. J Anal Toxicol. 2008;32(3):253-259. doi:10.1093/jat/32.3.253
  • 30. Chytil L, Štícha M, Matoušková O, Perlík F, Slanař O. Enatiomeric determination of tramadol and O-desmethyltramadol in human urine by gas chromatography–mass spectrometry. J Chromatogr B. 2009;877(20-21):1937-1942. doi:10.1016/j.jchromb.2009.04.042

Determination of tramadol in pharmaceutical preparations by GC-MS method

Yıl 2025, Cilt: 5 Sayı: 1, 22 - 27, 25.06.2025

Bilal Yılmaz , Emrah Alkan

https://doi.org/10.5281/zenodo.15729141

Öz

In this study, a gas chromatography-mass spectrometry (GC-MS) method was developed to analyze tramadol in both pure form and pharmaceutical formulations. Diclofenac served as the internal standard. The linearity of the GC-MS method was validated within a concentration range of 0.05-5.0 μg mL-1. The intra- and inter-day relative standard deviations were found to be below 1.18% and 3.51%, respectively. The detection and quantification limits for the GC-MS method were determined to be 0.015 and 0.045 μg mL-1, respectively. Stability testing revealed that tramadol remained stable in solutions after 24 hours of incubation at room temperature or after 72 hours of storage at 4 °C and -20°C. Under the selected assay conditions, tablet excipients did not cause any
interference. Furthermore, the method proved to be effective in quantifying tramadol and ensuring the consistency of formulation content in commercial tramadol dosage forms.

Anahtar Kelimeler

Tramadol GC-MS Validation Tablet

Kaynakça

  • 1. Gibson TP. Pharmacokinetics, efficacy, and safety of analgesia with a focus on tramadol HCl. Am J Med. 1996;101:S47-S53. doi:10.1016/S0002-9343(96)00138-6
  • 2. Shipton EA. Tramadol—Present and Future. Anaesth Intensive Care. 2000;28(4):363-374. doi:10.1177/0310057X0002800403
  • 3. Cooper RJ. Over-the-counter medicine abuse – a review of the literature. J Subst Use. 2013;18(2):82-107. doi:10.3109/14659891.2011.615002
  • 4. Almér Herrnsdorf E, Holmstedt A, Håkansson A. Tramadol misuse in treatment-seeking adolescents and young adults with problematic substance use – Prediction of treatment retention. Addict Behav Reports. 2022;16:100446. doi:10.1016/j.abrep.2022.100446
  • 5. Miotto K, Cho AK, Khalil MA, Blanco K, Sasaki JD, Rawson R. Trends in Tramadol: Pharmacology, Metabolism, and Misuse. Anesth Analg. 2017;124(1):44-51. doi:10.1213/ANE.0000000000001683
  • 6. Allegaert K, Anderson BJ, Verbesselt R, et al. Tramadol disposition in the very young: an attempt to assess in vivo cytochrome P -450 2D6 activity. Br J Anaesth. 2005;95(2):231-239. doi:10.1093/bja/aei170
  • 7. Goeringer KE, Logan BK, Christian GD. Identification of Tramadol and its Metabolites in Blood from Drug-Related Deaths and Drug-Impaired Drivers. J Anal Toxicol. 1997;21(7):529-537. doi:10.1093/jat/21.7.529
  • 8. Quetglas EG, Azanza JR, Cardenas E, Sádaba B, Campanero MA. Stereoselective pharmacokinetic analysis of tramadol and its main phase I metabolites in healthy subjects after intravenous and oral administration of racemic tramadol. Biopharm Drug Dispos. 2007;28(1):19-33. doi:10.1002/bdd.526
  • 9. Ardakani YH, Rouini M. Pharmacokinetics of tramadol and its three main metabolites in healthy male and female volunteers. Biopharm Drug Dispos. 2007;28(9):527-534. doi:10.1002/bdd.584
  • 10. El-Sayed A-AY, Mohamed KM, Nasser AY, Button J, Holt DW. Simultaneous determination of tramadol, O-desmethyltramadol and N-desmethyltramadol in human urine by gas chromatography–mass spectrometry. J Chromatogr B. 2013;926:9-15. doi:10.1016/j.jchromb.2013.02.019
  • 11. Ghasemi E. Optimization of solvent bar microextraction combined with gas chromatography mass spectrometry for preconcentration and determination of tramadol in biological samples. J Chromatogr A. 2012;1251:48-53. doi:10.1016/j.chroma.2012.06.060
  • 12. Sha YF, Shen S, Duan GL. Rapid determination of tramadol in human plasma by headspace solid-phase microextraction and capillary gas chromatography–mass spectrometry. J Pharm Biomed Anal. 2005;37(1):143-147. doi:10.1016/j.jpba.2004.09.050
  • 13. Rudaz S, Veuthey JL, Desiderio C, Fanali S. Simultaneous stereoselective analysis by capillary electrophoresis of tramadol enantiomers and their main phase I metabolites in urine. J Chromatogr A. 1999;846(1-2):227-237. doi:10.1016/S0021-9673(99)00028-X
  • 14. Valle M, Pavón J., Calvo R, Campanero M., Trocóniz I. Simultaneous determination of tramadol and its major active metabolite O-demethyltramadol by high-performance liquid chromatography with electrochemical detection. J Chromatogr B Biomed Sci Appl. 1999;724(1):83-89. doi:10.1016/S0378-4347(98)00547-7
  • 15. Ceccato A, Vanderbist F, Pabst J-Y, Streel B. Enantiomeric determination of tramadol and its main metabolite O-desmethyltramadol in human plasma by liquid chromatography–tandem mass spectrometry. J Chromatogr B Biomed Sci Appl. 2000;748(1):65-76. doi:10.1016/S0378-4347(00)00318-2
  • 16. Musshoff F, Madea B, Stuber F, Stamer UM. Enantiomeric Determination of Tramadol and O-Desmethyltramadol by Liquid Chromatography-Mass Spectrometry and Application to Postoperative Patients Receiving Tramadol. J Anal Toxicol. 2006;30(7):463-467. doi:10.1093/jat/30.7.463
  • 17. Musshoff F, Trafkowski J, Kuepper U, Madea B. An automated and fully validated LC‐MS/MS procedure for the simultaneous determination of 11 opioids used in palliative care, with 5 of their metabolites. J Mass Spectrom. 2006;41(5):633-640. doi:10.1002/jms.1021
  • 18. Zhu T, Ding L, Guo X, Yang L, Wen A. Simultaneous Determination of Tramadol and Acetaminophen in Human Plasma by LC–ESI–MS. Chromatographia. 2007;66(3-4):171-178. doi:10.1365/s10337-007-0268-9
  • 19. Campanero MA, Calahorra B, García-Quetglás E, Escolar M, Honorato J. High-performance liquid chromatographic assay for simultaneous determination of tramadol and its active metabolite in human plasma. Application to pharmacokinetic studies. Chromatographia. 1998;48(7-8):555-560. doi:10.1007/BF02466649
  • 20. Nobilis M, Kopecký J, Květina J, et al. High-performance liquid chromatographic determination of tramadol and its O-desmethylated metabolite in blood plasma. J Chromatogr A. 2002;949(1-2):11-22. doi:10.1016/S0021-9673(01)01567-9
  • 21. Campanero MA, Garcı́a-Quetglas E, Sádaba B, Azanza JR. Simultaneous stereoselective analysis of tramadol and its primary phase I metabolites in plasma by liquid chromatography. J Chromatogr A. 2004;1031(1-2):219-228. doi:10.1016/j.chroma.2003.11.034
  • 22. Pedersen RS, Brøsen K, Nielsen F. Enantioselective HPLC method for quantitative determination of tramadol andO-desmethyltramadol in plasma and urine: Application to clinical studies. Chromatographia. 2003;57(5-6):279-285. doi:10.1007/BF02492397
  • 23. Rouini M-R, Ardakani YH, Soltani F, Aboul-Enein HY, Foroumadi A. Development and validation of a rapid HPLC method for simultaneous determination of tramadol, and its two main metabolites in human plasma. J Chromatogr B. 2006;830(2):207-211. doi:10.1016/j.jchromb.2005.10.039
  • 24. LI Q, Wang R. Simultaneous analysis of tramadol, metoprolol and their metabolites in human plasma and urine by high performance liquid chromatography. Chin Med J (Engl). 2006;119(23). https://journals.lww.com/cmj/fulltext/2006/12010/simultaneous_analysis_of_tramadol,_metoprolol_and.12.aspx
  • 25. Validation of analytical procedures: Text and Methodology. In: International Conference on Harmonization (ICH). Commission of the European Communities. Vol 2. ; 1996.
  • 26. Gan S., Ismail R. Validation of a high-performance liquid chromatography method for tramadol and o-desmethyltramadol in human plasma using solid-phase extraction. J Chromatogr B Biomed Sci Appl. 2001;759(2):325-335. doi:10.1016/S0378-4347(01)00237-7
  • 27. Ardakani YH, Rouini M-R. Improved liquid chromatographic method for the simultaneous determination of tramadol and its three main metabolites in human plasma, urine and saliva. J Pharm Biomed Anal. 2007;44(5):1168-1173. doi:10.1016/j.jpba.2007.04.012
  • 28. Moore C, Rana S, Coulter C. Determination of meperidine, tramadol and oxycodone in human oral fluid using solid phase extraction and gas chromatography–mass spectrometry. J Chromatogr B. 2007;850(1-2):370-375. doi:10.1016/j.jchromb.2006.12.008
  • 29. Cheng P-S, Lee C-H, Liu C, Chien C-S. Simultaneous Determination of Ketamine, Tramadol, Methadone, and their Metabolites in Urine by Gas Chromatography-Mass Spectrometry. J Anal Toxicol. 2008;32(3):253-259. doi:10.1093/jat/32.3.253
  • 30. Chytil L, Štícha M, Matoušková O, Perlík F, Slanař O. Enatiomeric determination of tramadol and O-desmethyltramadol in human urine by gas chromatography–mass spectrometry. J Chromatogr B. 2009;877(20-21):1937-1942. doi:10.1016/j.jchromb.2009.04.042
Toplam 30 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Mikro ve Nanosistemler
Bölüm Research Articles
Yazarlar

Bilal Yılmaz 0000-0002-8574-7570

Emrah Alkan 0000-0002-0020-7170

Erken Görünüm Tarihi 24 Haziran 2025
Yayımlanma Tarihi 25 Haziran 2025
Gönderilme Tarihi 4 Mart 2025
Kabul Tarihi 10 Haziran 2025
Yayımlandığı Sayı Yıl 2025 Cilt: 5 Sayı: 1

Kaynak Göster

 Kapak Resmi İndir

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