Liquid Chromatographic Determination of Nystatin in Pharmaceutical Preparations

Author:

Wilson Phyllis1,Stewart Ann1,Flournoy Valerie2,Zito S William3,Vancura Ales3

Affiliation:

1. U.S. Food and Drug Administration, NRL, 158-15 Liberty Ave, Jamaica, NY 11433

2. U.S. Food and Drug Administration, CDER, 8301 Muirkirk Rd, Laurel, MD 20708

3. St. John's University, 8000 Utopia Parkway, Jamaica, NY 11439

Abstract

Abstract A rapid, reversed-phase liquid chromatographic method was developed for the assay of nystatin in the bulk drug and a variety of dosage forms. Analysis was performed on a Symmetry C18 reversed-phase column using a mobile phase of methanol–water–dimethylformamide (DMF; 55 + 30 + 15, v/v/v), with detection by UV at 305 nm. Quantitation is based on the sum of the peak areas of the 2 major isomers of nystatin. The linearity of the assay was determined for a concentration range of 0.05 to 0.2 mg/mL (correlation coefficient > 0.999). Accuracies and precision showed good reproducibility.

Publisher

Oxford University Press (OUP)

Subject

Pharmacology,Agronomy and Crop Science,Environmental Chemistry,Food Science,Analytical Chemistry

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