Spectrophotometric Assay of Prothipendyl through the Determination of Its Sulfoxide

Authors

  • Olena Mozgova Institute of Physical Chemistry, Polish Academy of Sciences, Kasprzaka 44/52, 01-224 Warsaw, Poland http://orcid.org/0000-0003-0875-7035
  • Mykola Blazheyevskiy Department of General Chemistry, National University of Pharmacy, Pushkinska 53, Kharkiv 61168, Ukraine
  • Liubomyr Kryskiw Department of Pharmaceutical Chemistry, I. Horbachevsky Ternopil National Medical University, Ruska 36, Ternopil 46001, Ukraine
  • Tetyana Kucher Department of Pharmaceutical Chemistry, I. Horbachevsky Ternopil National Medical University, Ruska 36, Ternopil 46001, Ukraine
  • Valeriy Moroz Department of General Chemistry, National University of Pharmacy, Pushkinska 53, Kharkiv 61168, Ukraine

DOI:

https://doi.org/10.17721/fujcV11I2P47-56

Keywords:

difference spectrophotometry, assay, azaphenothiazine, prothipendyl, S-oxidation, oxone

Abstract

A new difference spectrophotometric method for the analysis of prothipendyl hydrochloride in commercial pharmaceutical preparations has been proposed. The method includes oxidation of an aliquot of the drug solution with potassium caroate to form the corresponding sulfoxide (ε278 = (13.69 ±0.01)×103 L mol/cm) and subsequent measurement of the optical density of the solution at 278 nm compared to that of the unoxidized drug solution of equal concentration. The graph of Beer's law for prothipendyl hydrochloride shows that the ΔA values measured at the corresponding wavelength are proportional to the concentration of the drug in the concentration range of 3.2-60 µg/mL. The characteristics of the curve calibration curve of the linear regression equation were as follows: ΔА = (0.0342±0.0006)C + (0.0501±0.025) (where C in μg/mL). The resulting difference in absorbance is independent of the presence of excipients and degradation products in the formulation. A new spectrophotometric technique has been developed and the possibility of quantitative determination of prothipendyl hydrochloride monohydrate in Dominal® tablets of 40 mg has been demonstrated. RSD =1.4% (δ= – 0.42%).

References

Apotheker-Verein S. Index Nominum 2000: International Drug Directory. Vol. 17. Taylor & Francis; 2000.

Elks J. The dictionary of drugs: chemical data: chemical data, structures and bibliographies. Springer; 2014.

Leigh D, Pare CM, Marks J. A concise encyclopaedia of psychiatry. Springer Science & Business Media; 2012.

Reynolds JEF. Martindale: the extra pharmacopoeia. London, UK; The Pharmaceutical Press; 1982.

Greenstein GR. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals (14th edition). Reference Reviews 2007;21(6):40-40. https://doi.org/10.1108/09504120710775534

Debailleul G, Khalil F, Lheureux P. HPLC Quantification of Zolpidem and Prothipendyl in a Voluntary Intoxication. Journal of Analytical Toxicology 1991;15(1):35-37. https://doi.org/10.1093/jat/15.1.35

Diehl G, Karst U. Post-column oxidative derivatization for the liquid chromatographic determination of phenothiazines. Journal of Chromatography A 2000;890(2):281-287. https://doi.org/10.1016/s0021-9673(00)00607-5

Krämer M, Heese P, Banger M, Madea B, Hess C. Range of therapeutic prothipendyl and prothipendyl sulfoxide concentrations in clinical blood samples. Drug Testing and Analysis 2017;10(6):1009-1016. https://doi.org/10.1002/dta.2319

Kumazawa T, Hasegawa C, Uchigasaki S, Lee X, Suzuki O, Sato K. Quantitative determination of phenothiazine derivatives in human plasma using monolithic silica solid-phase extraction tips and gas chromatography–mass spectrometry. Journal of Chromatography A 2011;1218(18):2521-2527. https://doi.org/10.1016/j.chroma.2011.02.070

Blazheyevskiy MY. Spectrophotometric and spectrofluorimetric determination of the 2-and 10-disubstituted phenothiazines using peroxy acid oxidation. Curr Top Anal Chem 2019;11:67-80.

Misiuk W, Kleszczewska E. Application of ammonium peroxidisulfate and metavanadate for spectrophotometric determination of prothipendyl hydrochloride. Acta Pol Pharm 2001;58(2):87-92.

Nascentes C, Cárdenas S, Gallego M, Valcárcel M. Continuous photometric method for the screening of human urines for phenothiazines. Analytica Chimica Acta 2002;462(2):275-281. https://doi.org/10.1016/s0003-2670(02)00317-3

Puzanowska-Tarasiewicz H, KuŹmicka L, KarpiŃska J, Mielech-Łukasiewicz K. Efficient Oxidizing Agents for Determination of 2,10-Disubstituted Phenothiazines. Analytical Sciences 2005;21(10):1149-1153. https://doi.org/10.2116/analsci.21.1149

Krämer M, Broecker S, Madea B, Hess C. Confirmation of metabolites of the neuroleptic drug prothipendyl using human liver microsomes, specific CYP enzymes and authentic forensic samples—Benefit for routine drug testing. Journal of Pharmaceutical and Biomedical Analysis 2017;145:517-524. https://doi.org/10.1016/j.jpba.2017.07.011

Davidson A. The determination of phenothiazine drugs in pharmaceutical preparations by a difference spectrophotometric method. Journal of Pharmacy and Pharmacology 1976;28(11):795-800. https://doi.org/10.1111/j.2042-7158.1976.tb04059.x

Görög S. Ultraviolet-Visible Spectrophotometry in Pharmaceutical Analysis. CRC press; 1995. https://doi.org/10.1201/9781351077422

Blazheyevskiy M. Application Derivatization By Means Perhydrolysis Reactions In Pharmaceutical Analysis. Methods and Objects of Chemical Analysis 2017;12(1):31-54. https://doi.org/10.17721/moca.2017.31-54

Blazheyevskiy MY. Application of derivatization by means of peroxy acid oxidation and perhydrolysis reactions in pharmaceutical analysis. Lviv: Ivan Franko National University of Lviv. 2017.

Crandall J, Shi Y, Burke C, Buckley B. Potassium Monoperoxysulfate. Encyclopedia of Reagents for Organic Synthesis 2012. https://doi.org/10.1002/047084289x.rp246.pub3

Spiro M. The standard potential of the peroxosulphate/sulphate couple. Electrochimica Acta 1979;24(3):313-314. https://doi.org/10.1016/0013-4686(79)85051-3

De Leenheer A. Ultraviolet Spectrophotometry of Phenothiazine Derivatives and Analogs.Journal of the Association of Official Analytical Chemists. 1973;56(1):105-18. https://doi.org/10.1093/jaoac/56.1.105

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2023-12-25

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