VALIDATION UV QUANTITATIVE DEFINITION OF DICLOFENAC SODIUM IN SUPPOSITORIES
It is designed reproducible, sensitive and precise Spectrophotometric method for determination of diclofenac sodium in suppositories. The coefficient of variation specificity is 0.18 (CV<2%). Thus, the specificity of the developed method meets the requirements made to the analytical methods. The relative standard deviation for 50 mg diclofenac sodium suppositories is - 0.16 and for 100 mg suppositories - 0.12% (criteria for acceptability of < 2.0%). The accuracy (systematic error of an analytical method)for the 50 mg diclofenac sodium suppositories is - 1.12 and for 100 mg suppositories - 0.12% (acceptability criteria < 5.0%). The correlation coefficient for 50 mg diclofenac sodium suppositories is - 0.9985 and for 100 mg suppositories is0.9963%. The method is linear from 8.0 - 13.0 mg/ml for 50 mg diclofenac sodium suppositories and from 8.2 to-13.4 mg/ml for 100 mg suppositories. Thus, the results received during validation of an analytical method of definition of diclofenac sodium in suppositories, 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.