Determination of Voriconazole and its Degradation products in Pharmaceutical formulations using High Performance Liquid Chromatography with Ultra-Violet Detection
More details
Hide details
SIGMA Pharmaceuticals Corporation, Zagazig, Egypt
Zagazig University, Analytical Chemistry Department, Faculty of Pharmacy, Zagazig, Egypt
Abdalla Shalaby   

Zagazig University, Analytical Chemistry Department, Faculty of Pharmacy, Zagazig, Egypt
Publication date: 2017-10-08
Eurasian J Anal Chem 2010;5(3):254–264
Simple, sensitive and accurate stability indicating analytical method has been developed and validated for determination of voriconazole and its degradation products using RP-HPLC method with ultra-violet detection. The resulting method was applied for determination of voriconazole tablets (Vfend®). The procedure was developed and validated under acidic, basic, oxidative and photo-irradiated conditions. The compounds were separated on C18 column using 0.05M disodium hydrogen phosphate buffer (pH 5.5) : acetonitrile (1:1, v/v) as a mobile phase. at a flow rate of 1.0 ml per min and UV detection at 255 nm, the run time was less than 15 minutes The calibration curves were linear between 6.0 and 60 µg/ml. The proposed method was simple, highly sensitive, precise, accurate and, is useful for routine quality control analysis and stability testing. It was found that voriconazole was more sensitive to the basic conditions, photodegradation was observed only under severe conditions of light exposure and oxidation may also appear, however, it was stable in acidic medium.
VFEND (voriconazole) (2002) Tablets and injection [package insert]. New York: Pfizer, Inc;.
Hoffman H L, Rathbun R C (2002) Review of the safety and efficacy of voriconazole. Expert Opin Investig Drugs 11:409–429.
Pfaller M A, Messer S A, Hollis R J, Jones R N, Diekema D J (2002) In vitro activities of ravuconazole and voriconazole compared with those of four approved systemic antifungal agents against 6, 970 clinical isolates of Candida.
Purkins L, Wood N, Gharamani P, Greenhalgh K, Allen M J, Kleinermans D (2002) Antimicrob Agents Chemother 46: 2546.
Egle H, Trittler R, Koenig A, Kuemmerer K (2005) J Chromatogr B: Anal Technol Biomed Life Sci 814(2): 361.
Keevil B G, Newman S, Lockhart S, Howard S J, Moore C B, Denning D W (2004) Ther Drug Monit 26(6): 650.
Pehourcq F, Jarry C, Bannwarth B (2004) Biomed Chromatogr 18 (9) 719.
Zhou L, Glickman R D, Chen N, Sponsel W E, Graybill J R, Lam K W (2002) J Chromatogr B: Anal Technol Biomed Life Sci 776(2): 213.
Ferretti R, Gallinella B, La Torre F, Zanitti L (1998) Chromatographia 47 (11–12) 649.
Owens P K, Fell A F, Coleman M W, Berridge J C (1999) Enantiomer 4 (2) 79.
FDA Guidance for Industry (1997) Dissolution Testing of Immediate Releas Solid Oral Dosage Forms, Food and Drug Administration, Rockville.
International Conference on Harmonisation Topic Q2B, Validation of Analytical Methods: Methodology. The Third International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Yokohama-Japan.
Vander H, Nijhuis A, Smeyers V J, Vandeginste D L (2001) J Pharm Biomed Anal 24: 723.