Development spectrophotometric method of determination mebhydrolin in dosage forms

Authors

  • Святослав Леонідович Загородній Zaporozhye State Medical University 26 Mayakovsky str., Zaporizhzhya, Ukraine, 69035, Ukraine
  • Світлана Олександрівна Васюк Zaporozhye State Medical University 26 Mayakovsky str., Zaporizhzhya, Ukraine, 69035, Ukraine

DOI:

https://doi.org/10.15587/2313-8416.2015.57217

Keywords:

spectrophotometry, sulfоnephthalein dyes, mebhydrolin napadizilat, bromothymol blue, analysis, quantitative determination

Abstract

Allergic diseases have a clear tendency to increase worldwide. Mebhydrolin napadizilat is one of the most famous antihistamines H1-receptor blockers. Mebhydrolin high therapeutic activity, as well as low price leads to its popularity. Drugs based on it are produced by leading pharmaceutical companies in Ukraine. The development of simple and precise methods for quantitative determination of mebhydrolin in dosage forms is an actual problem of modern pharmaceutical analysis.

Aim: The development of high sensitive, convenient and cheap methods for spectrophotometric quantitative determination of mebhydrolin in pharmaceutical phormulations. The methods validation according to the requirements of the State Pharmacopoeia of Ukraine.

Methods: Absorption of the reaction products of mebhidrolin and bromtymol blue was measured in the wavelength range of 350-700 nm using spectrophotometer Specord 200.

Results: A new spectrophotometric method for quantitative determination of mebhydrolin was developed. The method is based on mebhydrolin interaction with bromothymol blue in chloroform with ion-pair complex formation (maximum absorption at 412 nm). The new technique is applied to dosage forms - tablets, dragees and pellets produced by Ukrainian pharmaceutical companies. Main characteristics of validation requirements of the State Pharmacopoeia of Ukraine were determined. It is proved that the method can be correctly reproduced and is suitable for use in pharmaceutical and other chemical analytical laboratories

Author Biographies

Святослав Леонідович Загородній, Zaporozhye State Medical University 26 Mayakovsky str., Zaporizhzhya, Ukraine, 69035

Assistant

Department of Analytical Chemistry

Світлана Олександрівна Васюк, Zaporozhye State Medical University 26 Mayakovsky str., Zaporizhzhya, Ukraine, 69035

Doctor of Pharmacy, Professor

Head of the Department of Analytical Chemistry

References

Harkevich, D. A. (1999) Farmakologiya: uchebnik dlya studentov vyisshih uchebnyih zavedeniy. Sixth edition. Moscow: «Geotar meditsina», 661.

Kovalenko, V. N., Viktorova, A. P. (2008). Kompendium 2008 – Lekarstvennyie preparatyi. Kyiv: «Morion», 2250.

Wulandari, L., Yuwono, M., Indrayanto, G. (2012). Densitometric determination of mebhydrolin napadisylate in tablets. Journal of Planar Chromatography – Modern TLC, 25 (1), 60–64. doi: 10.1556/jpc.25.2012.1.10

Wulandari, L. (2008). Determination and validation of mebhydroline napadisylate in tablets by HPLC. Indo. J. Chem., 8 (3), 377–379.

Mantrov, G. I., Shevchuk, I. K. (2012). Ionselektivnyiy elektrod dlya opredeleniya mebgidrolina (diazolina) v farmatsevticheskih preparatah. Vestnik TvGU seriya «Himiya», 14, 43–47.

Sastry, C. S. P., Prasad, T. A. S. R., Suryanarayana, M. V. (1990). Extraction-spectrophotometric determination of some antihistaminic agents with fast green FCF. Mikrochim Acta, 100 (1-2), 107–112. doi: 10.1007/bf01244506

Sastry, C. S. P., Tipirneni, A. S. R. P., Suryanarayana, M. V. (1990). Spectrophotometric determination of some antiallergic agents with 3-methyl-2-benzothiazolinone hydrazone. Journal of Pharmaceutical and Biomedical Analysis, 8 (3), 287–292. doi: 10.1016/0731-7085(90)80039-r

Tadzhieva, A. D. (2000). Izuchenie stabilnosti i skorosti vyisvobozhdeniya diazolina iz iz tabletok Diafita. Voprosyi biologicheskoy, meditsinskoy i farmatsevticheskoy himi, 2, 43–44.

Amin, A. S., El-Fetouh Gouda, A. A., El-Sheikh, R., Zahran, F. (2007). Spectrophotometric determination of gatifloxacin in pure form and in pharmaceutical formulation. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 67 (5), 1306–1312. doi: 10.1016/j.saa.2006.09.041

Marona, H. R., Schapoval, E. E. (2001). Spectrophotometric determination of sparfloxacin in Pharmaceutical formulations using bromothimol blue. Journal of Pharmaceutical and Biomedical Analysis, 26 (3), 501–504. doi: 10.1016/s0731-7085(01)00429-0

Ulu, S. T., Aydogmus, Z. (2008). A New Spectrophotometric Method for the Determination of Tianeptine in Tablets Using Ion-Pair Reagents. Chemical & pharmaceutical bulletin, 56 (12), 1635–1638. doi: 10.1248/cpb.56.1635

Sudhir Kumar, R., Manjunatha, D. H., Shaikh, S. M. T., Seetharamappa, J., Harikrishna, K. (2006). Sensitive Extractive Spectrophotometric Methods for the Determination of Trazodone Hydrochloride in Pharmaceutical Formulations. Chemical & pharmaceutical bulletin, 54 (7), 968–971. doi: 10.1248/cpb.54.968

Derzhavna Farmakopeia Ukraini [State Pharmacopoeia of Ukraine]. 1st edition. (2008). Charkov: Naukovo-ekspertnii farmakopeinii centr Derzhavna Farmakopeya Ukrayini. First edition (2008). Harkiv: Derzhavne pidpriemstvo «Naukovo-ekspertniy farmakopeyniy tsentr», 620.

Published

2015-12-29

Issue

Section

Pharmaceutical Sciences