A method for accelerated determination of active pharmaceutical ingredients (APIs) in Tetralgin combined preparation was developed based on preliminary extraction separation of the components followed by preparation of their aqueous extracts and voltammetric titration by a solution of photogenerated iodine obtained via irradiation of an auxiliary solution containing potassium iodide, a mixture of sensitizers (sodium eosinate:fluorescein:auramine, 1:1:1 mole ratio), and acetate buffer (pH 5.6). Extraction (CHCl3) separation of the drug components allowed extraction from a model solution of up to 97% caffeine (pH 11.0 – 12.0) and 98% phenobarbital (pH 4.0 – 5.0). The found contents of Tetralgin APIs were within the range recommended by GPM 1.4.2.0009.15 so that the quality of the drug met GMP standards.
Similar content being viewed by others
References
P. M. Clarke and A. V. Avery, Med. J., 200(9), 518 – 520 (2014); https://doi.org/10.5694/mja14.00199.
W. Sun, P. Sanderson, and W. Zheng, Drug Discov. Today, 21(7), 1189 – 1195 (2016); https://doi.org/10.1016/j.drudis.2016.05.015.
T. Kabir, S. Uddin, A. A. Mamun, et al., Int. J. Mol. Sci., 21(9), 3272 (2020); https://doi.org/10.3390/ijms21093272.
S. Yu. Martsevich, Yu. V. Lukina, A. D. Deev, et al., Ratsion. Farmakoter. Kardiol., No. 3, 29 – 34 (2005).
G. Schoretsanitis, E. Spina, C. Hiemke, and J. de Leon, Expert Rev. Clin. Pharmacol., 10(9), 965 – 981 (2017); https://doi.org/10.1080/17512433.2017.1345623.
C. K. S. Ong, P. Lirk, C. H. Tan, and R. A. Seymour, Clin. Med. Res., 5(1), 19 – 34 (2007); https://doi.org/10.3121/cmr.2007.698.
M. R. Siddiquia, Z. A. AlOthmana, and N. Rahman, Arabian J. Chem., 10, 1409 – 1421 (2017); https://doi.org/10.1016/j.arabjc.2013.04.016.
S. Mennickent, M. de Diego, et al., in: Quality Control of Herbal Medicines and Related Areas, Y. Shoyama (ed.), InTech, Rijeka, Croatia (2011), Chap. 8, pp. 145 – 160; https://doi.org/10.5772/23475.
M. G. El-Bardicy, M. F. El-Tanas, and E. S. El-Zanfally, Spectrosc. Lett., 30(2), 267 – 287 (1997); https://doi.org/10.1080/00387019708006987.
10. M.Wojciak-Kosior, A. Skalska, G. Matysik, and M. Kryska, J. AOAC Int., 89(4), 995 – 998 (2006); https://doi.org/10.1093/jaoac/89.4.995.
Y. Hori, M. Fujisawa, K. Shimada, et al., Biol. Pharm. Bull., 29(1), 7 – 13 (2006); https://doi.org/10.1248/bpb.29.7.
G. Ragab, H. Saleh, M. El-Henawee, and O. F. Elsayed, Eurasian J. Anal. Chem., 11(4), 197 – 210 (2016).
O. L. Mezentseva, G. B. Slepchenko, V. D. Filimonov, et al., Anal. Kontrol, 22(2), 206 – 213 (2018); https://doi.org/10.15826/analitika.2018.22.2.011.
S. Z. Yao, J. Pharm. Biomed. Anal., 5(4), 325 – 331 (1987); https://doi.org/10.1016/0731-7085(87)80038-9.
E. V. Turusova, O. E. Nasakin, et al., RU Pat. 122,490, Nov. 27, 2012.
G. Loos, A. V. Schepdael, and D. Cabooter, Philos. Trans. R. Soc., A, 374, No. 2079, 20150366 (2016); https://doi.org/10.1098/rsta.2015.0366.
B. R. Rader and E. S. Aranda, J. Pharm. Sci., 57(5), 847 – 851 (1968); https://doi.org/10.1002/jps.2600570528.
N. N. Azwanida, Med. Aromat. Plants, 4(3), 1000196 (2015); https://doi.org/10.4172/2167-0412.1000196.
W. Feng, M. Li, Z. Hao, and J. Zhang, “Analytical methods of isolation and identification,” in: Phytochemicals in Human Health, V. Rao, D. Mans, and L. Rao (eds.), Intechopen, (2020); Chap. 3; https://doi.org/10.5772/intechopen.88122.
A. Severina and V. Petrenko, SU Pat. 691,740, Oct. 15, 1979.
J. N. Valenta, R. P. Dixon, A. D. Hamilton, and S. G Weber, Anal. Chem., 66(14), 2397 – 2403 (1994); https://doi.org/10.1021/ac00086a028.
D. N. Bailey and M. Kelner, J. Anal. Toxicol., 8(1), 26 – 28 (1984); https://doi.org/10.1093/jat/8.1.26.
A. I. Zhebentyaev, Vestn. Farm., No. 1, 50 – 55 (2009).
Author information
Authors and Affiliations
Corresponding author
Additional information
Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 55, No. 7, pp. 55 – 59, July, 2021.
Rights and permissions
About this article
Cite this article
Turusova, E.V., Nasakin, O.E. Photogenerated Iodine for Determination of Active Pharmaceutical Ingredients in Tetralgin Drug. Pharm Chem J 55, 740–744 (2021). https://doi.org/10.1007/s11094-021-02486-x
Received:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11094-021-02486-x