RP-HPLC-UV Detection Method for the Simultaneous Determinat ion of Econazole Nitrate, Triamcinolone Acetonide and Benzoic Acid in Ternary Mixture

Author(s): Asmaa A. EL-Zaher, Ehab F. Elkady, Amaal A. Al-Tahami*

Journal Name: Current Pharmaceutical Analysis

Volume 15 , Issue 7 , 2019

Become EABM
Become Reviewer
Call for Editor

Graphical Abstract:


Background: Econazole nitrate and triamcinolone acetonide are one of the topical antifungal corticosteroid fixed combinations. Although this combination has been literately investigated, yet their ternary mixture with benzoic acid as preservative lack of a simple method for its determination.

Objective: The objective of this work is to present simple, accurate, precise and low cost reversed-phase liquid chromatography (RP-LC) method for the separation and determination of econazole nitrate, triamcinolone acetonide and benzoic acid in a ternary mixture.

Methods: Separation was conducted on Mediterranea C18 (150mm x 4.6mm, 5μm) column using methanol: 50 mM potassium dihydrogen phosphate buffer (pH 2.60±1), (70:30, v/v) as a mobile phase at ambient temperature. Isocratic flow rate at 1 ml/min was used and UV detection was carried out at 230 nm. The Linearity, accuracy and precision of the developed method investigated as per ICH guidelines.

Results: Good separation of two drugs, benzoic acid as preservative and excipients of dosage form was achieved with acceptable retention times (< 8 min). Validation parameters tested including linearity, accuracy and precision were found to be satisfactory over the concentration range (10-200 µg/ml) for econazole nitrate, (1-20 µg/ml) for triamcinolone acetonide and (2-40 μg/ml) for benzoic acid.

Conclusion: The proposed method showed good separation and demonstrated adequate specificity, robustness and accuracy for the quantification of the tested drugs in laboratory prepared mixtures and in pharmaceutical preparations.

Keywords: Econazole nitrate, triamcinolone acetonide, banzoic acid, reversed-phase liquid chromatography, pharmaceutical preparation, ternary mixture.

Brunton, L.L.; Chabner, B.; Knollmann, B.C. Goodman & Gilman’s the pharmacological basis of therapeutics, 11th ed; NewYork: McGraw-Hill Medical, 2011.
John, M.B.; John, H.B. Wilson and Gisvold’s textbook of organic medicinal and pharmaceutical chemistry, 12th ed; Philadelphia: Lippincott Williams & Wilkins, 2011.
Finkel, R.; Clark, M.A.; Cubeddu, L.X. Pharmacology, 4th ed; Philadelphia: Lippincott Williams & Wilkins, 2009.
Carlos, G.; Uribe, P.; Fernández-Peñas, P. Rational use of topical corticosteroids. Aust. Prescr., 2013, 36(5), 158-161.
G.B.S, Office. U.K. S. Office, British Pharmacopoeia 2014; Stationery Office, 2014.
U.S.P, Convention. USP 39 NF 34: United States Pharmacopeia, National Formulary, United States Pharmacopoeial Convention 2015.
Ekiert, R.J.; Krzek, J. Determination of azole antifungal medicines using zero-order and derivative UV spectrophotometry. Acta Pol. Pharm., 2009, 66(1), 19-24.
Cavrini, V.; Di Pietra, A.M.; Gatti, R. Analysis of miconazole and econazole in pharmaceutical formulations by derivative UV spectroscopy and liquid chromatography (HPLC). J. Pharm. Biomed. Anal., 1989, 7(12), 1535-1543.
Čakar, M.; Popović, G.; Agbaba, D. High-performance thin-layer chromatography determination of some antimycotic imidazole derivatives and preservatives in medicinal creams and a gel. J. AOAC Int., 2005, 88(5), 1544-1548.
Čakar, M.; Popović, G.; Vladimirov, S. Simultaneous HPTLC determination of imidazole antimycotics and parabens in creams. Planar. Chromat. J., 2004, 17(3), 177-180.
Khashaba, P.Y.; El-Shabouri, S.R.; Emara, K.M.; Mohamed, A.M. Analysis of some antifungal drugs by spectrophotometric and spectrofluorimetric methods in different pharmaceutical dosage forms. J. Pharm. Biomed. Anal., 2000, 22(2), 363-376.
Arranz, A.; Echevarría, C.; Moreda, J.M.; Cid, A.; Arranz, J.F. Capillary zone electrophoretic separation and determination of imidazolic antifungal drugs. J. Chromatogr. A, 2000, 871(1), 399-402.
Selvadurai, M.; Choong, A.C.T.; Lian, H.Y.L.; Xian, T.H.; Pin, T.H.; Chien, W.C.; Dhanaraj, S.A. Simple and sensitive method development and validation of Econazole in human plasma by RP-HPLC. Int. J. Drug Deliv., 2014, 6(1), 94.
Gaona-Galdos, A.A.; García, P.L.; Aurora-Prado, M.S.; Santoro, M.I.R.M.; Kedor-Hackmann, É.R.M. Simultaneous determination of econazole nitrate, main impurities and preservatives in cream formulation by high performance liquid chromatography. Talanta, 2008, 77(2), 673-678.
Xia, Y.; Zhi, X.; Wang, X.; Chen, M.; Cheng, J. Ultrasound-enhanced surfactant-assisted dispersive liquid–liquid microextraction and high-performance liquid chromatography for determination of ketoconazole and econazole nitrate in human blood. Anal. Bioanal. Chem., 2012, 402(3), 1241-1247.
Christinat, R.; Zulliger, H.W. Stability indicating HPLC-method for the determination of econazole nitrate in cream and lotion formulations. Arzneimittelforschung, 1984, 34(5), 551-553.
Pereira, A.D.; Santos, M.C.M.; Costa, V.M.; Pianetti, G.A.; Da Silva, G.R. Development and validation of a high performance liquid chromatographic method for determination of triamcinolone acetonide from polyurethane intraocular implants. Int. J. Pharm. Pharm. Sci., 2012, 4(4), 132-136.
Muralidharan, S.; Venugopal, V.; Kumar, J.; Parasuraman, S. Development and validation of a new RP-HPLC method for the analysis of triamcinolone in human plasma. Turk. J. Pharm. Sci., 2016, 13(1), 9-16.
César, I.C.; Byrro, R.M.D. de Santana e Silva Cardoso, F.; Mundim, I.M.; de Souza Teixeira, L.; de Sousa, W.C.; Pianetti, G.A. Determination of triamcinolone in human plasma by a sensitive HPLC–ESI‐MS/MS method: application for a pharmacokinetic study using nasal spray formulation. J. Mass Spectrom., 2011, 46(3), 320-326.
Xiao-li, Y.; Zhi-fang, X.; Jin-fang, S. Determination of compound econazole nitrate cream by reverse phase ion-pair gradient elution HPLC. Chin. J. Ant., 2004, 29(7), 403-405.
Baker, M.M.; Belal, T.S.; Mahrous, M.S.; Ahmed, H.M.; Daabees, H.G.A. Validated stability-indicating HPLC-DAD method for simultaneous determination of econazole nitrate, triamcinolone acetonide, benzoic acid and butylated hydroxyanisole in cream dosage form. Anal. Methods, 2016, 8(10), 2185-2200.
Qiu, S.; Kai, Liu. K.; Ma, P.; Wang, M.; Chen, H.; Xu, X.; Hao, X.; Wang, Y. Simultaneous analysis of losartan potassium and its related impurities and degradation products in tablets using HPLC. Curr. Pharm. Anal., 2015, 11(1), 25-34.
International Conferenace on Harmonisation (ICH), validation of analytical procedures: text and methodology, Q2(R1),, 2005.

Rights & PermissionsPrintExport Cite as

Article Details

Year: 2019
Published on: 14 October, 2019
Page: [738 - 744]
Pages: 7
DOI: 10.2174/1573412914666180501113706
Price: $65

Article Metrics

PDF: 36
PRC: 1