VALIDATION OF UV SPECTROPHOTOMETRIC QUANTITATIVE DETERMINATION METHOD OF DIZOL TABLETS

Authors

  • Baramidze K. ბარამიძე ქ.
  • Baramidze K. კუნჭულია ლ.
  • Tefnadze L. ტეფნაძე ლ.
  • Chikviladze T. ჩიკვილაძე თ.
  • Gabrichidze S. გაბრიჭიძე ს.

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Abstract

Precise, sensitive and reproduced UV spectrophotometric method for determination of Dizol tablets is designed.  The coefficient of variation specificity is 0.15 and 0,19 (CV<2%). Thus, the specificity of the developed method meets the requirements made to the analytical methods. The relative standard deviation for 500 mg Dizol tablets is – 0,16 and 0,03 (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 Dizol tablets is – 0,53% (acceptability criteria <2.0%). Thus, the accuracy of the developed method meets the requirements made to the analytical methods. The correlation coefficient for Dizol tablets is - 0.996. The method is linearity from 0.016 – 0.024 mg/ml for Dizol tablets. 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 ornidazole in Dizol tablets, 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.

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References

USP 39 NF 34, <197>, <851> (2016)

European Pharmacopoea 8Ed (2014)

РУКОВОДСТВО по валидации методик анализа лекарственных средств. Под редакцией: Н.В. Юргеля, А.Л. Младенцева, А.В. Бурдейна, М.А. Гетьмана, А.А.Малина; (2016)

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;

ICH Q2 A (CPMP/ICH/381/95), Validation of analytical procedure: Methodology, London UK, 1997.

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Published

2021-06-18

How to Cite

ბარამიძე ქ. B. K., კუნჭულია ლ. B. K., ტეფნაძე ლ. T. L., ჩიკვილაძე თ. C. T., & გაბრიჭიძე ს. G. S. (2021). VALIDATION OF UV SPECTROPHOTOMETRIC QUANTITATIVE DETERMINATION METHOD OF DIZOL TABLETS. COLLECTION OF SCIENTIFIC WORKS OF TBILISI STATE MEDICAL UNIVERSITY, 50, 24–26. Retrieved from https://journals.4science.ge/index.php/CSW/article/view/10

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