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.
Llabot
Juan M
JM
Departamento de Farmacia, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Ciudad Universitaria, 5000 Córdoba, Argentina.
Allemandi
Daniel A
DA
Manzo
Ruben H
RH
Longhi
Marcela R
MR
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