Alternative method for determination of voriconazole impurity E

Voriconazole is an antifungal medication that is included on the WHO Model list of Essential Medicines. During synthesis of the active ingredient a resolving agent for chiral amines is often used, and it is thus necessary that the quality control prove that this substance is not present at harmful levels in the final product.

The original pharmacopoeia monograph method for the synthesis residue camphor-10-sulfonic acid in voriconazole, stipulates the use of a column with a strongly basic anion-exchange resin and a basic hydroxide eluent containing 25% methanol. Diduco have developed a new alternative method for the determination of voriconazole impurity E using a more straightforward carbonate-based eluent and a much more hydrophilic column, thus requiring only 5% organic solvent. This new quality control method was developed according to the ICH guidelines and meets the system suitability criteria of the original method.

Alternative method for voriconazole impurity E

Alternative to European Pharmacopoeia 9.0 method (monograph 2017:3921). Ion chromatography separation of Voriconazole related substances impurity E and chloride on a Shodex IC SI-90 4E column (250×4 mm) using an eluent containing 95% aqueous 4 mM NaHCO₃ and 0.5 mM Na₂CO₃ with 5% acetonitrile, pumped at 1.5 mL/min at 25 °C. Background reduced by XAMS suppressor with ASUREX-A200 automatic regenerator. Eluent pumping and conductivity detection by Metrohm 761 Compact IC. Injection of 20 µL of chloride (5 mg/L), and voriconazole impurity E (camphor-10-sulfonic acid, 20 mg/L) in water, giving signals up to about 2.5 µS/cm.

Diduco is a leading provider of professional services in high performance liquid chromatography and manufacturer of the Xenoic® XAMS chemical suppressor and ASUREX automatic regenerator for ion chromatography.

Diduco AB
Tvistevägen 48C
90736 Umeå

Service inquiry

OEM Request