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DEVELOPMENT AND VALIDATION OF A SPECTROFLUORIMETRIC METHOD FOR THE DETERMINATION OF PHENIBUT IN TABLET DRUGS

Abstract

The developed method for the quantitative determination of phenibut in tablet drugs is based on the dansylation reaction in an alkaline medium (pH 9.18). The reaction results in the formation of a fluorescent derivative with λem=505 nm and λex=335 nm. Optimal conditions were selected to complete the reaction: temperature and time of thermostatting (40 °C and 15 min), molar ratio of phenibut and dansyl chloride (1:1.4). The method was validated in parameters of specificity, linearity, precision and accuracy. A plot of fluorescence intensity versus concentration of phenibut over the range of 800-1200 ng/ml is described by the regression equation y =0.1003x+1.4685 ( r =0.9999). The limit of detection and limit of quantification were 29.55 и 89.54 ng/ml respectively.

About the Authors

O. I. Lazovskaya
Belarusian State Technological University
Belarus


V. N. Leontiev
Belarusian State Technological University
Belarus


E. V. Litvinova
RUE «Belmedpreparaty»
Belarus


References

1. М.Д. Машковский. Лекарственные средства. - М.: Новая волна, 2012. 1216 с.

2. I. Lapin. Phenibut (beta-phenyl-GABA): a tranquilizer and nootropic drug // CNS Drug Reviews. 2001. V. 7. № 3. P. 471-481.

3. M. Dambrova, L. Zvejniece, E. Liepinsh et al. Comparative pharmacological activity of optical isomers of phenibut // European Journal of Pharmacology. 2008. V. 583. № 1. P. 128-134.

4. L. Logoyda, D. Korobko, N. Zarivna et al. Development of methodology for the spectrophotometric determination of phenibut in drugs // 19th Dubai International Pharmaceuticals and Technologies Conference and Exhibition, March 10-12, 2014. - Dubai. 2014. P. 157.

5. Б.В. Боровский. Валидационная оценка спектрофотометрической методики количественного определения фенибута в таблетках по реакции с нингидрином // Научное обозрение. 2013. № 4. С. 222-225.

6. Ю.А. Полковникова, У.А. Тульская. Разработка методики количественного определения фенибута в микрокапсулах // Материалы V Всероссийской научно-практической конференции «Беликовские чтения», 6-7 декабря 2016 г. - Пятигорск. 2016. С. 66-68.

7. L. Logoyda, D. Korobko, N. Zarivna. Development of methodology for the determination of phenibut in medicines / 2nd Chemical Engineering and Chemical Technologies Conference, October 23-25, 2014. - Istanbul. 2014. P. 141-153.

8. Н.Л. Векшин. Флуоресцентная спектроскопия биополимеров. - Пущино: Фотон-век, 2014. 188 с.

9. Z. Aydogmus, F. Sari, S.T. Ulu. Spectrofluorimetric determination of aliskiren in tablets and spiked human plasma through derivatization with dansyl chloride // Journal of Fluorescence. 2012. V. 22. № 2. P. 549-556.

10. E.S. Aktas, L. Ersoy, O. Sagirli. A new spectrofluorimetric method for the determination of lisinopril in tablets // IL Farmaco. 2003. V. 58. № 2. P. 165-168.

11. N. El-Enany, F. Belal, M. Rizk. Spectrofluorimetric determination of oxamniquine in dosage forms and spiked human plasma through derivatization with 1-dimethylaminonaphthalene-5-sulphonyl chloride // Journal of Fluorescence. 2008. V. 18. № 2. P. 349-355.

12. G. Iskender, S. Atmaca. Spectrofluorimetric determination of nortriptyline hydrochloride with NBD-Cl in pharmaceutical dosage forms // Journal of Pharmacy of University of Marmara. 1986. V. 2. № 1. P. 69-76.

13. ГОСТ 8.135-2004. Государственная система обеспечения единства измерений. Стандарт-титры для приготовления буферных растворов - рабочих эталонов рН 2-го и 3-го разрядов. Технические и метрологические характеристики. Методы их определения. - М.: Стандартинформ, 2005. 12 с.

14. F. Garcia Sanchez, C. Cruces Blanco. Determination of the insecticide promecarb by fluorogenic labelling with dansyl chloride // Analyst. 1991. V. 116. № 8. P. 851-856.

15. А.А. Шеряков. Государственная фармакопея Республики Беларусь. Т. 1. Общие методы контроля качества лекарственных средств. - Молодечно: Победа, 2012. 1220 с.


Review

For citations:


Lazovskaya O.I., Leontiev V.N., Litvinova E.V. DEVELOPMENT AND VALIDATION OF A SPECTROFLUORIMETRIC METHOD FOR THE DETERMINATION OF PHENIBUT IN TABLET DRUGS. Drug development & registration. 2017;(4):104-107. (In Russ.)

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ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)