VALIDATION OF UV SPECTROPHOTOMETRIC QUANTITATIVE DETERMINATION METHOD OF FLUCOVID CAPSULES

Authors

  • Baramidze K. ბარამიძე ქ.
  • Kunchulia L. კუნჭულია ლ.
  • Koberidze N. კობერიძე ნ.
  • Chikviladze T. ჩიკვილაძე თ.
  • Ashortia I. აშორტია ი.

DOI:

https://doi.org/10.52340/csw.2016.50.0.26-28

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Abstract

Precise, sensitive and reproduced UV spectrophotometric method for determination of Flucovid kapsules is designed. The coefficient of variation specificity is 0.16 and 0,20 (CV≤2%). Thus, the specificity of the developed method meets the requirements made to the analytical methods. The relative standard deviation for 150 mg Flucovid kapsules is – 0,11 and 0,21 (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 150 mg Flucovid capsules is – 0,55% (acceptability criteria ≤2.0%). Thus, the accuracy of the developed method meets the requirements made to the analytical methods. The correlation coefficient for 150 mg Flucovid capsules is - 0.998. The method linearity is from 0.16 – 0.24 mg/ml for 150 mg Flucovid capsules. 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 fluconazole in Flucovid 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, Fluconazole (2016)

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. K. L., კობერიძე ნ. K. N., ჩიკვილაძე თ. C. T., & აშორტია ი. A. I. (2021). VALIDATION OF UV SPECTROPHOTOMETRIC QUANTITATIVE DETERMINATION METHOD OF FLUCOVID CAPSULES. TSMU COLLECTION OF SCIENTIFIC WORKS, 50, 26–28. https://doi.org/10.52340/csw.2016.50.0.26-28

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