Affiliation:
1. Department of Chemistry, Vel’s Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram-600117, India
Abstract
A novel, rapid, simple and cost-effective RP-HPLC method was developed for the assay of flucytosine
and its related substances in drug product (tablets). The developed method was subjected to validation
challenges as per the ICH guidelines and the method found to follow all the validation challenges
successfully. Method employed uses a column with L1 end-capped stationary phase having dimensions
of 250 mm × 4.6 mm, 5 μm. The mobile phase comprised of 10 mM phosphate buffer and methanol in
gradient mode. The detection was performed at 210 nm. The flucytosine peak eluted at about 5.5 min
making the method cost-effective. In this method, the related substances were also quantified. Owing
to short run time, simple chromatographic conditions and sample preparation, the method is claimed
to be ideal for the routine high throughput analysis leading to low cost of testing.
Publisher
Asian Journal of Chemistry