Liquid chromatographic determination of flucytosine in capsules: collaborative study.
A liquid chromatographic method for the determination of flucytosine in capsules was collaboratively studied by 7 laboratories. The method uses a C18 reverse phase column, water-methanol-acetic acid mobile phase containing 1-octanesulfonic acid sodium salt, p-aminobenzoic acid as internal standard, and photometric detection at 285 nm. The mean recovery value (+/- SD) of flucytosine from a synthetic formulation representing capsules was 99.2 +/- 1.72% (CV = 1.73%). Composited samples of 250 and 500 mg commercial capsules gave assay values of (mean +/- SD) 103.17 +/- 2.21 and 99.29 +/- 1.29% of declared, respectively. CV values were 2.15 and 1.30%. Reproducibility and repeatability CVs were 2.19 and 1.50%, respectively, for the 250 mg capsules, and 1.34 and 0.63%, respectively, for the 500 mg capsules. The method has been adopted official first action.
Shostak
D
D
Food and Drug Administration, New York Regional Laboratory, Brooklyn 11232-1593.
Klein
C
C
D002214:Capsules; D002853:Chromatography, Liquid; D005437:Flucytosine / Q000008:administration & dosage / Q000032:analysis*
D002214:Capsules; D005437:Flucytosine