A method for accelerated determination of diphenhydramine hydrochloride (dimedrol, DPH) in liquid and solid dosage forms (DFs) that is based on titration of the analytical form with a solution of photogenerated iodine obtained by irradiation of an auxiliary solution containing potassium iodide and uranine at pH 6.0 has been developed. Stabilization of the current in the amperometric circuit indicated that the reaction was complete and; therefore, provided control of the DPH content in the DF because the titrant content in the solution was controlled by a voltammetric method (amperometric titration with two polarized electrodes). Further irradiation of the solution and measurement of the time required to regenerate the lost titrant also made it possible to regulate the DPH content in the DF. The technique was tested on a solid DF and sterile solutions of DPH intended for intramuscular and intravenous administration. Stabilizers (HCl, lactose monohydrate) present in the DF had insignificant effects on photogeneration of the titrant. The dependence of the analytical signal on DPH concentration was linear in the range 0.1 – 20.0 mg for the drug “Diphenhydramine, tablets 50 mg.” The limits of detection (DL) and quantitation (LOQ) for this drug that were calculated from the changes in the current and regeneration time were (1.26; 0.108) mg and (0.382; 0.329) mg, respectively. The developed photochemical method of determination complies with the requirements in the guidelines for validation of bioanalytical methods. The method is easy to use and does not require expensive equipment. Therefore, it can be recommended for routine control of the quality indicators under control or analytical laboratory conditions.
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M. V. Kuznetsova, S. S. Ryasenskii, and I. P. Gorelov, Khim.-farm. Zh., 37(11), 34 – 36 (2003); Pharm. Chem. J., 37(11), 599 – 601 (2004); https://doi.org/10.1023/B:PHAC.0000016072.20948.49.
S. Ashour and H. Aboudan, Int. J. Pharm. Chem., 4, 8 – 15 (2018); 10.11648 / j.ijpc.20180401.12.
O. Mamina, V. Kabachny, T. Tomarovska, and N. Bondarenko, ScienceRise: Pharm. Sci., 4(26), 18 – 24 (2020); https://doi.org/10.15587/2519-4852.2020.210728.
S. D. Yoo, J. E. Axelson, and D. W. Rurak, J. Chromatogr., 378(2), 385 – 393 (1986).
D. Lutz, W. Gielsdorf, and H. Jaeger, J. Clin. Chem. Clin. Biochem., 21, 595 – 597 (1983).
B. Devrim, E. Dinc, and A. Bozkir, Acta Pol. Pharm. Drug Res., 71(5), 721 – 729 (2014).
M. Hurtado and J. R. Medina, Int. J. App. Pharm., 9(6), 106 – 109 (2017).
Yu. V. Slustovskaya, V. S. Kasheutova, and O. Yu. Strelova, Farmatsiya, 66(3), 12 – 16 (2017).
S. M. Drogovoz, V. D. Luk?yanchuk, B. S. Sheiman, and A. V. Kononenko, Suchasni Prob. Toksikol., 3 – 4, 44 – 48 (2012).
A. V. Katilov, N. I. Sinchuk, D. V. Dmitriev, and A. V. Mazulov, Med. Svitu, 13(5) (2007); http://msvitu.com/archive/2007/november/article-6-ru.php.
E. A. Porsukov, Sud. Med., 6(2), 41 – 43 (2020).
T. V. Polenova, I. V. Martsenko, A. G. Borzenko, and I. A. Revel’skii, Zh. Anal. Khim., 58(7), 711 – 712 (2003).
A. B. Melent’ev, Quantitative Determination Method for Morphine, Codeine and Dimedrol in Blood by Gas Chromatography with a Mass-Selective Detector (Blopypro Method) [in Russian], Chelyabinsk. Obl. Byuro SME, Chelyabinsk (2002).
A. M. El-Didamony and M. A. Moustafa, Arabian J. Chem., 3(4), 265 – 270 (2010).
E. M. Abdel-Moety and M. G. El-Bardicy, Anal. Lett., 18(17), 2155 – 2172 (1985); https://doi.org/10.1080/00032718508067978.
S. L. Zagorodniy and S. O. Vasyuk, Zaporozh. Med. Zh., No. 2, 89 – 92 (2015); https://doi.org/10.14739/2310-1210.2015.2.42122.
H. Y. Harahap and M. O Puspasari, Trop. J. Pharm. Res., 16(10), 2501 – 2506 (2017); 10.4314 / tjpr.v16i10.25.
Z. K. Ge, Y. H. Luo, X. Y. Zhao, et al., Afr. J. Pharm. Pharmacol., 5(18), 2100 – 2105 (2011); https://doi.org/10.5897/AJPP11.582.
E. E. Muller and J. Sherma, J. Liq. Chromatogr. Relat. Technol., 22(1), 153 – 159 (1999).
E. Y. Z. Frag, G. G. Mohamed, and W. G. El-Sayed, Bioelectrochemistry, 82(2), 79 – 86 (2001); https://doi.org/10.1016/j.bioelechem.2011.05.006.
M. A. E. Ries and S. Khalil, J. Pharm. Biomed. Anal., 25(1), 3 – 7 (2001); 10.1016 / S0731-7085(00)00459-3.
M. M. Osmanova and Kh. A. Mirzaeva, Zavod. Lab., Diagn. Mater., 83(12), 21 – 23 (2017); https://doi.org/10.26896/1028-6861-2017-83-12-21-23.
K. Mirzaeva, M. Akhmedova, A. Ramazanov, and S. A. Akhmedov, J. Anal. Chem., 59(3), 215 – 218 (2004); https://doi.org/10.1023/B:JANC.0000018961.36565.da.
M. Haag, M. Bruning, and K. Molt, Anal. Bioanal. Chem., 395(6), 1777 – 1785 (2009); https://doi.org/10.1007/s00216-009-3130-0.
E. V. Turusova, A. N. Lyshchikov, and O. E. Nasakin, RU Pat. 122490, Nov. 27, 2012; Byull., No. 33 (2012).
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 56, No. 12, pp. 60 – 65, December, 2022.
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Turusova, E.V., Nasakin, O.E. Voltammetric Determination of Diphenhydramine Hydrochloride in Solid and Liquid Dosage Forms. Pharm Chem J 56, 1671–1676 (2023). https://doi.org/10.1007/s11094-023-02842-z
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DOI: https://doi.org/10.1007/s11094-023-02842-z