Authors
Dvorskaya O. N.
Doctor of Pharmacy, Assistant Professor, Head, Chair for Pharmacy and Chemistiry, Faculty of Pharmacy1
Nozhkina N. N.
Senior Lecturer, Chair for Pharmacy and Chemistiry, Faculty of Pharmacy1
1 - South-Ural State Medical University, Chelyabinsk, Russia
Corresponding Author
Dvorskaya Oksana, e-mail: dvoksnik@gmail.com
Funding
The study had no sponsorship.
Conflict of interest
None declared.
Abstract
A technique has been developed based on reversed-phase high-performance liquid chromatography with diode-matrix detection for the joint determination of succinic acid and cetylpyridinium chloride in complex action medicinal films. Efficient chromatographic separation of active drug components was achieved in a gradient elution mode on a Luna C18 (2) 100A column (4.6 × 250 mm, 5 µm) using a mobile phase consisting of a 0.1% solution of phosphoric acid and acetonitrile. The detection wavelength was 210 nm for both compounds. The developed method is validated in terms of specificity, linearity, precision, accuracy and can be used to determine the authenticity and quantitative content of succinic acid and cetylpyridinium chloride in the joint presence in assessing the quality of medicinal films.
Key words
medicinal films, succinic acid, cetylpyridinium chloride, high performance liquid chromatography, gradient elution
DOI
References
1. Amelin, V.G., Bol'shakov D.S. Identifikacija i odnovremennoe opredelenie chetvertichnyh ammonievyh soedinenij s drugimi dejstvujushhimi veshhestvami v lekarstvennyh preparatah metodom zhidkostnoj hromatomass-spektrometrii. [Simultaneous identification and determination by LC-MS of quaternary ammonium compounds with other active ingredients in drugs] Himiko-farmacevticheskij zhurnal [Pharmaceutical Chemistry Journal] 2020; 54(1): 54-60. doi: 10.30906/0023-1134-2020-54-1-54-60 (In Russ.)
2. Vorob'ev A.N., Petrov A.Ju. Ispol'zovanie metoda VJeZhH dlja kolichestvennogo opredelenija cinnarizina i kisloty jantarnoj pri sovmestnom prisutstvii [Assay of cinnarizine and succinic acid in a combined mixture by HPLC method]. Chelovek i ego zdorov'e [Humans and their health] 2009; (2): 130-133. (In Russ.)
3. Dzjuba V.F., Slivkin A.I., Suslina S.N. et al. Razrabotka metodov standartizacii novyh nootropnyh preparatov na osnove pantogama i kisloty jantarnoj s ispol'zovaniem fiziko-himicheskih metodov. [Development of methods for standardization of the new preparations with pantogam and siccine acid with use of physical and chemical methods] Vestnik Voronezhskogo gosudarstvennogo universiteta, seriya Himiya. Biologiya. Farmaciya [Proceedings of Voronezh State University. Series: Chemistry. Biology. Pharmacy] 2011; (1): 177-185. (In Russ.)
4. Kravec O.N. Vyyavlenie i korrekciya narushenij svobodnoradikal'nogo okisleniya v rotovoj zhidkosti pri hronicheskom generalizovannom parodontite. Avtoref. diss. kand. med. nauk: 14.00.21. [Detection and correction of disorders of free radical oxidation in the oral fluid in chronic generalized periodontitis. Author’s abstract, PhD Thesis. Ufa. 2007. (In Russ.)
5. Leonov K.A., Pustovojtov A.V., Vishenkova D.A. Sovmestnoe opredelenie jantarnoj kisloty i vodorastvorimyh vitaminov metodom ion-parnoj vysokojeffektivnoj zhidkostnoj hromatografii [Simultaneous determination of succinic acid and water-soluble vitamins by ion-pair high-performance liquid chromatography]. Zhurnal analiticheskoj himii [Journal of Analytical Chemistry] 2018; 73(4): 271–277. doi: 10.7868/S0044450218040047 (In Russ.)
6. Nozhkina N.N., Sinickij A.I., Simonjan E.V. Ocenka antioksidantnogo dejstvija biorastvorimoj lekarstvennoj plenki s kislotoj jantarnoj i cetilpiridinija hloridom. [Evaluation of antioxidant action of biodegradable medicinal films containing succinic acid and cetylpyridinium chloride] Medicinskij vestnik Bashkortostana [Bashkortostan Medical journal] 2016; 5(65): 93-95. (In Russ.)
7. Nozhkina N.N., Simonyan E.V., Sinitsky A.I., et al. Patent RUS ¹ 2617238 C1. Sposob polucheniya lekarstvennogo sredstva s kislotoy yantarnoy i tsetilpiridiniy khloridom mestnogo deystviya. [Method for preparation of drug with amber acid and cetylpyridinium chloride with local action]. Available at: https://www.elibrary.ru/download/elibrary_38263097_43306100.pdf
8. WHO web-site. https://who.int/ru/
9. Abdelwahab N.S., Ali N.W., Abdelkawy M., Emam A.A. Validated RP-HPLC and TLC-Densitometric Methods for Analysis of Ternary Mixture of Cetylpyridinium Chloride, Chlorocresol and Lidocaine in Oral Antiseptic. Formulation Journal of Chromatographic Science 2016; 54(3): 318-325.
10. Belal T.S., Shaalan R.A., Haggag R.S. et al. Gradient HPLC-Diode Array Detector Stability-Indicating Determination of Lidocaine Hydrochloride and Cetylpyridinium Chloride in Two Combined Oral Gel Dosage Forms. Journal of AOAC International 2011; 94(2): 503-512.
11. Lian H. Z., Mao L., Ye X.L., Miao J. Simultaneous determination of oxalic, fumaric, maleic and succinic acids in tartaric and malic acids for pharmaceutical use by ion-suppression reversed-phase high performance liquid chromatography. Journal of Pharmaceutical and Biomedical Analysis 1999; (19): 621-625.
12. Wang J., Lu J., Zhang L., Hu Y. Determination of cetylpyridinium chloride and tetracaine hydrochloride in buccal tablets by RP-HPLC. Journal of Pharmaceutical and Biomedical Analysis 2003; (32): 381-386. doi: 10.1016/s0731-7085(03)00108-0