Development and Validation of Novel RP-HPLC Method for Determination of Assay and Related Substances of Flucytosine in Drug Product

Development and Validation of Novel RP-HPLC Method for Determination of Assay and Related Substances of Flucytosine in Drug Product R. Saravanan Department of Chemistry, Vel’s Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram-600117, India https://orcid.org/0000-0003-0248-2835 T. Somanathan Department of Chemistry, Vel’s Institute of Science, Technology and Advanced Studies (VISTAS), Pallavaram-600117, India https://orcid.org/0000-0001-7879-5278

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.
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