Abstract (EN):
In this paper, a high performance liquid chromatography (HPLC) method was validated for quantification of clotrimazole (CTZ) loaded in a microemulsion (ME) or in a microemulsion-based gel (MBG). Both formulations are considered novel formulations for topical drug delivery. A C18 column (5 mu m, 150 x 4.6 mm) was used. A mixture of methanol and 0.025 M potassium dihydrogen phosphate (75:25 v/v) was selected as a mobile phase. The flow rate was controlled at 1.0 mL/min. The injection volume was 10 mu L. The wavelength detector was operated at 254 nm. The data were integrated with the RF 10A (version 1.1) LC software program. This method was found to give a sharp peak of CTZ at a retention time of 8.5 min. No interfering peaks of other components in the formulations were seen, percent recoveries were within 100 +/- 2%, and % RSD was not higher than 2, indicating for a high degree of specificity, accuracy, and precision, respectively. The linear regression analysis data for the calibration curve also exhibited a good linear relationship. CTZ was extracted from a ME or a MBG and then analyzed for the drug contents. From the reported experiments, the validated HPLC method demonstrated to be appropriate for quantitative assay of CTZ in the novel formulations.
Language:
English
Type (Professor's evaluation):
Scientific
No. of pages:
6