Volume 35, Issue 12 (12-2024)
Studies in Medical Sciences 2024, 35(12): 1035-1044 |
Back to browse issues page
Research code: 11025
Ethics code: IR.UMSU.REC.1400.395
Download citation:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:
Eskandari Azar M, Vardast M R. MEASUREMENT OF OXYTOCIN IN HUMAN SERUM AND PHARMACEUTICAL PRODUCTS AVAILABLE IN THE IRANIAN MARKET BY MICROEXTRACTION METHOD. Studies in Medical Sciences 2024; 35 (12) :1035-1044
URL: http://umj.umsu.ac.ir/article-1-6400-en.html
URL: http://umj.umsu.ac.ir/article-1-6400-en.html
Assistant Professor, Department of Medicinal Chemistry, Faculty of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran (Corresponding Author) , mrvardast@gmail.com
Abstract: (249 Views)
Background & Aims: Given the clinical importance and frequent use of oxytocin in serum and pharmaceutical products, along with the significant impact of improper dosage on both the therapeutic efficacy and adverse effects, this study aimed to develop and validate a dispersive liquid-liquid microextraction (DLLME) method for the rapid and precise measurement of oxytocin concentrations in these matrices.
Materials & Methods: In this study, a DLLME method was optimized using carbon tetrachloride as the extraction solvent and acetonitrile as the dispersing solvent. Various parameters, including temperature and stirring speed, were systematically investigated and optimized. Analyses were conducted using gas chromatography with flame ionization detection (GC-FID). The materials utilized included oxytocin, ethanol, methanol, acetone, dichloromethane, carbon tetrachloride, acetonitrile, and calcitonin (as the internal standard).
Results: Analysis of oxytocin concentrations in serum and commercial vials (5 and 10 IU/mL doses) from two domestic manufacturers (Company A and B) revealed that Company A’s products more closely matched their labeled concentrations compared to those of Company B. Method validation using a German reference standard (Rotexmedica) demonstrated comparable results for domestic samples, with no statistically significant differences observed. The analytical method showed excellent performance characteristics, with a linear detection range of 0.02–60 IU/mL, a calibration equation of A = 190731C − 21483, and a correlation coefficient (R²) of 0.999.
Conclusion: The developed DLLME method proved to be a simple, cost-effective, and reliable technique for quality control of oxytocin pharmaceutical preparations and the measurement of serum oxytocin levels. The findings revealed significant variations in oxytocin concentrations between different commercial products available in the Iranian market and demonstrated the method’s capability for accurate quantification in biological samples.
Materials & Methods: In this study, a DLLME method was optimized using carbon tetrachloride as the extraction solvent and acetonitrile as the dispersing solvent. Various parameters, including temperature and stirring speed, were systematically investigated and optimized. Analyses were conducted using gas chromatography with flame ionization detection (GC-FID). The materials utilized included oxytocin, ethanol, methanol, acetone, dichloromethane, carbon tetrachloride, acetonitrile, and calcitonin (as the internal standard).
Results: Analysis of oxytocin concentrations in serum and commercial vials (5 and 10 IU/mL doses) from two domestic manufacturers (Company A and B) revealed that Company A’s products more closely matched their labeled concentrations compared to those of Company B. Method validation using a German reference standard (Rotexmedica) demonstrated comparable results for domestic samples, with no statistically significant differences observed. The analytical method showed excellent performance characteristics, with a linear detection range of 0.02–60 IU/mL, a calibration equation of A = 190731C − 21483, and a correlation coefficient (R²) of 0.999.
Conclusion: The developed DLLME method proved to be a simple, cost-effective, and reliable technique for quality control of oxytocin pharmaceutical preparations and the measurement of serum oxytocin levels. The findings revealed significant variations in oxytocin concentrations between different commercial products available in the Iranian market and demonstrated the method’s capability for accurate quantification in biological samples.
Keywords: dispersive liquid-liquid microextraction, extraction solvent, method optimization, oxytocin quantification, microextraction
References
1. Haleem RM, Salem MY, Fatahallah FA, Abdelfattah LE. Quality in the pharmaceutical industry - A literature review. Saudi Pharm J 2015;23(5):463-9. [DOI:10.1016/j.jsps.2013.11.004] [PMID] []
2. Skoog DA, Holler FJ, Crouch SR. Principles of Instrumental Analysis. Cengage Learning; 2017. [google scholar]
3. Amidon GL, Lennernäs H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995;12(3):413-20. [DOI:10.1023/A:1016212804288] [PMID]
4. Beg S, Hasnain S, Rahman M, Swain S. Introduction to Quality by Design (QbD): Fundamentals, Principles, and Applications. Pharm Qual Des 2019. [DOI:10.1016/B978-0-12-815799-2.00001-0]
5. D'Atri V, Fekete S, Clarke A, Veuthey J-L, Guillarme D. Recent advances in chromatography for pharmaceutical analysis. Anal Chem 2019;91(1):210-39. [DOI:10.1021/acs.analchem.8b05026] [PMID]
6. Lambert P, Nguyen T-H, Oliver V, McArthur A, Goodall C, Teklu A, et al. Oxytocin injection quality in Ethiopia: a post-marketing surveillance study in public and private facilities across three regions. J Forensic Odontostomatol 2019;3. [DOI:10.29392/joghr.3.e2019081]
7. Gimpl G, Fahrenholz F. The oxytocin receptor system: structure, function, and regulation. Physiol Rev 2001;81(2):629-83. [DOI:10.1152/physrev.2001.81.2.629] [PMID]
8. Ivell R, Russell JA. Oxytocin: cellular and molecular approaches in medicine and research. Rev Reprod 1996;1(1):13-8. [DOI:10.1530/ror.0.0010013] [PMID]
9. Richard P, Moos F, Freund-Mercier MJ. Central effects of oxytocin. Physiol Rev 1991;71(2):331-70. [DOI:10.1152/physrev.1991.71.2.331] [PMID]
10. Macdonald K, Macdonald TM. The peptide that binds: a systematic review of oxytocin and its prosocial effects in humans. Harv Rev Psychiatry 2010;18(1):1-21. [DOI:10.3109/10673220903523615] [PMID]
11. Oral E, Gezer A, Cagdas A, Pakkal N. Oxytocin infusion in labor: the effect different indications and the use of different diluents on neonatal bilirubin levels. Arch Gynecol Obstet 2003;267(3):117-20. [DOI:10.1007/s00404-002-0298-3] [PMID]
12. Lee SY, Lee AR, Hwangbo R, Han J, Hong M, Bahn GH. Is Oxytocin Application for Autism Spectrum Disorder Evidence-Based? Exp Neurobiol 2015;24(4):312-24. [DOI:10.5607/en.2015.24.4.312] [PMID] []
13. Leng G, Sabatier N. Measuring Oxytocin and Vasopressin: Bioassays, Immunoassays and Random Numbers. J Neuroendocrinol 2016;28(10). [DOI:10.1111/jne.12413] [PMID] []
14. Liu D, Han X, Liu X, Cheng M, He M, Rainer G, et al. Measurement of ultra-trace level of intact oxytocin in plasma using SALLE combined with nano-LC-MS. J Pharm Biomed Anal 2019;173:62-7. [DOI:10.1016/j.jpba.2019.04.023] [PMID]
15. López-Arjona M, Mateo SV, Manteca X, Escribano D, Cerón JJ, Martínez-Subiela S. Oxytocin in saliva of pigs: an assay for its measurement and changes after farrowing. Domest Anim Endocrinol 2020;70:106384. [DOI:10.1016/j.domaniend.2019.106384] [PMID]
16. Moriyama E, Kataoka H. Automated analysis of oxytocin by on-line in-tube solid-phase microextraction coupled with liquid chromatography-tandem mass spectrometry. Chromatography 2015;2:382-91. [DOI:10.3390/chromatography2030382]
17. Akbari AZ, Heydari A. Quantification of oxytocin in pharmaceutical dosage forms available in drug market of Iran by using high performance liquid chromatography method (HPLC). Stud Med Sci 2014;24(12):956-65. [google scholar]
18. Viceconti M, Pappalardo F, Rodriguez B, Horner M, Bischoff J, Musuamba Tshinanu F. In silico trials: Verification, validation and uncertainty quantification of predictive models used in the regulatory evaluation of biomedical products. Methods 2021;185:120-7. [DOI:10.1016/j.ymeth.2020.01.011] [PMID] []
19. Ötles S, Kartal C. Solid-phase extraction (SPE): principles and applications in food samples. Acta Sci Pol Technol Aliment 2016;15(1):5-15. [DOI:10.17306/J.AFS.2016.1.1] [PMID]
20. Vardast MR, Ranjkeshzadeh N. New method for determination of amiodarone in serum with dispersive liquid-liquid microextraction by high-performance liquid chromatography with experimental method. Stud Med Sci 2020;31(1):7-14. [google scholar]
21. Vardast MR, Ranjkeshzadeh N, Ghasemlu K, Ranjkeshzadeh H. Evaluation of acrylamide in some fried products marketed in Urmia city by high performance liquid chromatographia with experimental method. Stud Med Sci 2019;30(3):207-16. [google scholar]
Send email to the article author
| Rights and permissions | |
 |
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
