How to Cite
Abstract
Precise, sensitive and reproduced titrimetric method for determination of clotrimazole in suppositories is designed. The coefficient of variation specificity is 0.28 (CV<2%). Thus, the specificity of the developed method meets the requirements made to the analytical methods. The relative standard deviation for 100 mg clotrimazole suppositories is - 1.47% (criteria for acceptability of < 2.0%). Thus, the precision of the developed method meets the requirements made to the analytical methods. Systematic error of an analytical method for the 100 mg clotrimazole suppositories is - 1.24% (acceptability criteria <2.0%). Thus, the accuracy of the developed method meets the requirements made to the analytical methods. _ The correlation coefficient for 100 mg clotrimazole suppositories is - 0.9978. The method linearity is from 80.0 120.0 mg/ml for 100 mg clotrimazole suppositories. Thus, linearity of the developed method meets the requirements made to the analytical methods. The results received during validation of an analytical method determination of clotrimazole 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, Precision, Linearity and Accuracy.
References
USP 39 NF 34, Clotrimazole (2016)
USP 39 NF 34, <541>, <451> (2016)
European Pharmacopoea 8 (2014)
Guidance for Industry Bioanalytical Method Valida- Ed tion 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;
ICH Q2 A (CPMP/ICH/381/95), Validation of analytical procedure: Methodology, London UK, 1997;