JOURNAL OF THE CZECH PHARMACEUTICAL SOCIETY AND THE SLOVAK PHARMACEUTICAL SOCIETY

Čes. slov. farm. 2023, 72(4):165-171 | DOI: 10.5817/CSF2023-4-165

Diazotization titrations in pharmacopoeial quality control of medicines and proposals for their revision in the European Pharmacopoeia

Jan Šubert, Jozef Kolář1,*, Jozef Čižmárik2,3
1 Ústav aplikované farmacie, Farmaceutická fakulta, Masarykova univerzita, Brno
2 Katedra farmaceutickej chémie FaF, Univerzita Komenského v Bratislave, Slovenská republika
3 Slovak Medical University in Bratislava, Slovak Republic

Based on the data in the Ph. Eur., some other newer pharmacopoeias and published experimental papers propose to revise the text of Ph. Eur. 2.5.8. First, it is necessary to specify which of the electrometric methods should be used to indicate the endpoint of diazotization titrations in Ph. Eur. (preferable potentiometry with a platinum indicating electrode). The amount of potassium bromide in the titration solution may be reduced to 1 g, the cooling of the solution before titration may be omitted from the framework procedure, and it may be specified in individual monographs if necessary to obtain accurate and correct results for some medicines. Diazotization titration can be performed in Ph. Eur. and can also be used to determine the content of some other medicines.

Keywords: titration of medicines with sodium nitrite; end-point indication; other conditions; Ph. Eur.

Received: April 14, 2023; Accepted: July 19, 2023; Published: April 1, 2023  Show citation

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Šubert J, Kolář J, Čižmárik J. Diazotization titrations in pharmacopoeial quality control of medicines and proposals for their revision in the European Pharmacopoeia. Čes. slov. farm. 2023;72(4):165-171. doi: 10.5817/CSF2023-4-165.
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    References

    1. Ph. Eur. 11th ed. 2022. https://www.edqm.eu/en/european-pharmacopoeia-ph.-eur.-11th-edition#%7B%22468819%22 (24. 2. 2023).
    2. The International Pharmacopoeia, 11th ed. Geneva: WHO 2022. https://digicollections.net/phint/2022/index.html#p/home(2.4.2023).
    3. British Pharmacopoeia 2022, Vol. I-V. London: The Stationery Office. https://www.webofpharma.com/2022/06/british-pharmacopoeia-2022-bp-2022-pdf.html (28. 1.2023).
    4. The United States Pharmacopeia 43 - The National Formulary 38, Volume 1-5, Baltimore: United Book Press, 2020. https://www.webofpharma.com/2022/01/usp-2021-united-state-pharmacopeia-44.html (28. 1. 2023).
    5. Československý lékopis, 4. vydání, svazek I. Praha: Avicenum 1987; 78.
    6. The Japanese Pharmacopoeia, 18th ed., English Version, The Ministry of Health, Labour and Welfare, 2021. https://www.mhlw.go.jp > content (28. 1. 2023).
    7. Indian Pharmacopoeia, 8th ed., Volume I-III, Ghaziabad: The Indian Pharmacopoeia Commission 2018. https://www.webofpharma.com/2022/04/indian-pharmacopoeia-2018-ip-2018-pdf.html (28. 1. 2023).
    8. Brazilian Pharmacopoeia, 6th ed., Volume I, MG5.3.3-00, Brasilia: Anvisa 2019. http://portal.anvisa.gov.br (28. 1.2023).
    9. Müller E., Dachselt E. Die potentiometrische Indikation der Diazotierung und quantitative Bestimmung von Aminen. Z. Elektrochem. 1925; 31, 662-666. Go to original source...
    10. Atanasiu J. A., Velculescu A. I. Potentiometrische Bestimmung von Benzidin durch Diazotierung. Ber. 1932; 65, 1080-1082. Go to original source...
    11. Singh B., Ahmed G. Potentiometric studies in diazotisation determination of aromatic amines. J. Indian Chem. Soc. 1938; 15, 416-420.
    12. Towne R. W., Hitchens R. M. Method of analysis for sulfanilamide. J. Am. Pharm. Assoc. 1939; 28, 585-588. https://doi.org/10.1002/jps.3080280904 (3. 2. 2023).
    13. Saeki T. Studies on quantitative analysis of aromatic amines by potentiometric titration. Yakugaku Zasshi 1950; 70, 660-668. https://doi.org/10.1248/yakushi1947.70.11_660 (27. 1. 2023). Go to original source...
    14. Larocca J. P., Waters, K. L. The potentiometric titration of the sulfa drugs. J. Am. Pharm. Assoc. Sci. Ed. 1950; 39, 521-523. Go to original source... Go to PubMed...
    15. Dušinský G. Potenciometrické stanovenie fenacetínu. Chem. Zvesti 1952; 6, 201-208.
    16. Butt L. T., Stagg H. E. The automatic titration of primary aromatic amines with nitrous acid. Anal. Chim. Acta 1958; 19, 208-215. https://doi.org/10.1016/S0003-2670(00)88144-1 (28. 1. 2023). Go to original source...
    17. Baldinus J. G., Rothberg I. The determination of acetophenetidin in tablet mixtures: A potentiometric method. J. Am. Pharm. Assoc. Sci. Ed. 1959; 48, 318-319. https://doi.org/10.1002/jps.3030480606 (7. 2. 2023). Go to original source... Go to PubMed...
    18. Čihalík J. Potenciometrie. Praha: Nakladatelství Československé akademie věd 1961; 683.
    19. Ueno K., Tachikawa T. Potentiometric titration of sulfanylamide with sodium nitrite. Japan Analyst 1962; 11, 554-558. Go to original source...
    20. Coenegracht P. M. J., Franke J. P., Metting, H. J. The automatic amperometric and potentiometric microtitration of pharmaceutically important sulfanilamide derivatives by diazotization with nitrite. Anal. Chim. Acta 1973; 65, 375-384. Go to original source... Go to PubMed...
    21. Badwan A. A., Jawan O. A., Owais L. Metoclopramide determination by amperometric and potentiometric titrations - application to some pharmaceutical preparations. Int. J. Pharm. 1986; 28, 41-46. https://doi.org/10.1016/0378-5173(86)90145-6 (7. 2. 2023). Go to original source...
    22. Šubert J. Příspěvky k analytice léčiv. VI. Studium podmínek pro diazotační titrace léčiv za potenciometrické indikace a standardizaci odměrného dusitanu sodného. Farm. Obzor 1981; 50, 273-278.
    23. Devi O. Z., Basavaiah K., Vinay K. B., Revanasiddappa H. D. Determination of metoclopramide hydrochloride in pharmaceuticals and spiked human urine through diazotization reaction. J. Food Drug Anal. 2012; 20, 4. https://doi.org/10.6227/jfda.2012200204 (7. 2. 2023).
    24. Zawada E., Pirianowicz-Chaber E., Somogi A., Pawinski T. Development and validation of bromatometric, diazotization and VIS-spectrophotometric methods for the determination of mesalazine in pharmaceutical formulation. Acta Pol. Pharm. 2017; 74, 401-404.
    25. Metrohm A. G.; Herisau. Nitrite titration according to USP general chapter <451>. Titration Application Note T-194 (2018). https://www.metrohm.com/en/applications/appli-cation-notes/aa-t-001-100/an-t-194.html (7. 2. 2023).
    26. Scholten H. G., Stone K. G. Determination of primary aromatic amines by diazotization using the dead-stop end point. Anal. Chem. 1952; 24, 749-750. Go to original source...
    27. Mohamed M. E., Abounassif M. A., Kandil H. A., Aboul-Enein H. Y. Biamperometric and differential pulse polarographic methods for the assay of nomifensine maleate. Anal. Lett. 1988; 21, 241-251. Go to original source...
    28. Arafat T. Bromhexine determination by diazotization using potentiometric titration: application to content uniformity. Anal. Lett. 1990; 23, 311-326. Go to original source...
    29. Arzneibuch der Deutschen Demokratischen Republik: AB-DDR 87. Berlin: Akademie-Verlag 1975-1987; VII,12.0.1. http://www.digibib.tu-bs.de/?docid=00000955(24. 2. 2019).
    30. Kucharský J., Erben J., Mikule V. Elektrometrická titrace sulfonamidů. Českoslov. Farm. 1954; 3, 284-285.
    31. Špinková V., Černý J. Jednoduché stanovení některých méně běžných sulfonamidů - 4-aminobenzensulfothiocarbamidu 4-aminomethylbenzensulfonamidu (Marbadal-Bayer) a směsi s 2-(4'-aminobenzensulfon amido)-4-methylpyrimidinem (Supronal-Bayer). Českoslov. Farm. 1958; 7, 591-593.
    32. Hrdý O., Jindra A., Jung Z., Šlouf A., Zýka J. Kvantitativní analysa léčiv. Praha: Státní zdravotnické nakladatelství 1957; 477.
    33. Portych J., Děťák J., Mareček Š., Lehký M. Základy farmaceutickej analýzy. Martin: Vydavateľstvo Osveta 1978, 181, 488.
    34. Bezáková Ž. Analýza chemických liečiv. Nitra: VA Print 2000; 128, 129.
    35. Connors K. A. Reaction Mechanisms in Organic Analytical Chemistry. New York: John Wiley 1973; 236-238.
    36. Matrka M., Pípalová J. K problematice potenciometrických titrací aromatických aminů dusitanem. Chem. Prům. 1973; 23, 149-152.
    37. Ågren A. Halbestämning av sulfonamider. Svensk Farm. Tidskr. 1951; 55, 229-238.
    38. Ph. Eur. 1st ed. 1969. Online: https://pheur.edqm.eu/app/arch/content/arch-0/1969_1st_Edition_Volume_I_E.pdf (27. 3. 2023).
    39. Ph. Eur. 2nd ed. 1980. Online: https://pheur.edqm.eu/app/arch/content/arch-0/1980_2nd_Edition_Part_I_E.pdf (27. 3. 2023).
    40. Ph. Eur. 3rd ed. 1996. Online: https://pheur.edqm.eu/app/arch/content/arch-0/1997_3rd_Edition_E.pdf (27. 3.2023).
    41. Kumara A., Singhb V., Kumarc P. Quantitative estimation of eflornithine by nitrite (diazotization) titration. Int. J. Pharm. Sci. 2016; 2, 12-14. https://www.metfop.edu.in/wp-content/uploads/2023/02/76836-paper-3.pdf (16. 3. 2023).

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