Разработка и регистрация лекарственных средств (Jan 2019)

DEVELOPMENT AND VALIDATION THE METHOD OF QUANTITATIVE DETERMINATION OF ETORICOXIB IN SOLID PHARMACEUTICAL FORMS BY HPLC

  • T. L. Batalova,
  • O. A. Ostapyuk,
  • K. R. Saveleva,
  • T. Y. Andreevicheva,
  • L. V. Persanova,
  • S. V. Polyakov,
  • V. N. Shestakov

Journal volume & issue
Vol. 0, no. 1
pp. 90 – 95

Abstract

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A sensitive and developed the validation method for quantification by using the chromatograph for Etoricoxib. The method was validated in terms of specificity, linearity, accuracy, precision and analytical range. The results of validation method and approbation at selected sites are given. It was shown than main validation characteristics meet the requirements. Using the HPLC method the dispersion was 0,253%. The analytical range of method is 25-85 µg/ml for HPLC.

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