USP Fluconazole and Related Impurities (TN-1276)

Abstract:

For this report, we focused on Fluconazole and related impurities as identified in the US Pharmacopeia monograph. We were able to show better resolution for Fluconazole and the related compound impurities versus the original column used in the monograph. The USP monograph requires that the resolution between Fluconazole related compound B and C be no less than 1.5 to meet system suitability; this was achieved here. In order to maximize performance and speed up analysis time, HPLC columns packed with core-shell (superficially porous) silica particles bonded with a C18 phase were used. The performance of the Kinetex core-shell columns used here was compared to that of the original column and all method parameters were consistent with the USP monograph for Fluconazole.

Document Type:

Technical Notes

Industries:

Pharmaceutical/Biopharmaceutical

Techniques:

HPLC / UHPLC

Brands:

Kinetex

PDF Link:

Click here