Impurity Analysis of Voriconazole According to USP Method (CDBS-453)

According to the United States Pharmacopeia (USP), a column packed with L45 is recommended for the analysis of voriconazole and its related substance B. Furthermore, it is necessary for the system suitability to satisfy the following resolution conditions:

1. Resolution of voriconazole and related substance B of ≥ 4.0
2. The tailing factor for related substance B must be ≤ 2.0
3. Relative standard deviation (RSD) must be ≤ 10.0 %.

The ORpak CDBS-453 satisfies all separation requirements.

Sample : 20 µL
(System suitability solution A)
1. Voriconazole 500 µg/mL
2. Voriconazole related compound B 2.5 µg/mL

Column       : Shodex ORpak CDBS-453 (4.6 mm I.D. x 150 mm)
Eluent       : Acetonitrile and *Buffer (13:87)
               *Buffer; 0.8 g/L of ammonium acetate.
                Adjust with glacial acetic acid to a pH of 5.0.
Flow rate    : 0.9 mL/min
Detector     : UV (256 nm)
Column temp. : 20 °C