HPLC method for the determination of nystatin in saliva for application in clinical studies.
An isocratic high-performance liquid chromatographic method was developed, optimized and validated for the determination of nystatin in human saliva (UV and fluorescence detection). A reversed-phase Luna C18 column (25 degrees C), with a mobile phase of MeOH, H2O, and DMF (70:20:10, v/v/v), and a flow-rate of 0.8 ml/min were used. The elution time for nystatin was 5.8+/-0.2 min. Calibration curves in human saliva were linear from 0.78 to 50 microg/ml. Limits of quantification were 0.78 microg/ml and 0.75 microg/ml for UV and fluorescence detection, respectively. The accuracy and precision values of intra- and inter-day variation studies were within acceptable limits, according to FDA guidelines. The described method has proved to be useful to give accurate measurements of nystatin in real samples.
Departamento de Farmacia, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Ciudad Universitaria, 5000 Córdoba, Argentina.
Juan M
JM
Llabot
Daniel A
DA
Allemandi
Ruben H
RH
Manzo
Marcela R
MR
Longhi
D000935:Antifungal Agents / Q000008:administration & dosage / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003692:Delayed-Action Preparations; D004355:Drug Stability; D006801:Humans; D015394:Molecular Structure; D009761:Nystatin / Q000008:administration & dosage / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D012463:Saliva / Q000737:chemistry*; D012680:Sensitivity and Specificity
D000935:Antifungal Agents; D003692:Delayed-Action Preparations; D009761:Nystatin