Spectrophotometric Assay of Prothipendyl through the Determination of Its Sulfoxide
DOI:
https://doi.org/10.17721/fujcV11I2P47-56Keywords:
difference spectrophotometry, assay, azaphenothiazine, prothipendyl, S-oxidation, oxoneAbstract
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
Downloads
Published
Issue
Section
License
Copyright (c) 2023 French-Ukrainian Journal of Chemistry
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).