VALIDATION HPLC QUANTITATIVE DEFINITION OF FLUCONAZOLE IN CAPSULES
It was designed reproducible, sensitive and precise High Pressure Liquid Chromatographic (HPLC) method for determination of fluconazole in capsules. The coefficient of variation specificity is 0.12 (CV<2%). Thus, the specificity of the developed method meets the requirements made to the analytical methods. The relative standard deviation for 50 mg fluconazole capsules is - 0.22% and for 150 mg capsules - 0.99% (criteria for acceptability of <2.0%). The accuracy (systematic error of an analytical method) for the 50 mg fluconazole capsules is - 2.05 and for 150 mg capsules - 1.08% (acceptability criteria <5.0%). The correlation coefficient for 50 mg fluconazole capsules is - 0.9974 and for 150 mg capsules is- 0.9968%. The method is linear from 40.0-60.0 mg/ml for 50 mg fluconazole capsules and from 120.0 to-180.0 mg/ml for 150 mg capsules. Thus, the results received during validation of an analytical method of definition of fluconazole in capsules, have shown full conformity of the developed method to requirements Guidance for Industry Bioanalytical Method Validation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) May 2001 on the following validation characteristics: Specificity, Accuracy.
2. ICH Q2 A (CPMP/ICH/381/95), Validation of analytical procedure: Methodology, London UK, 1997;
3. USP 38 NF 33