Разработка и регистрация лекарственных средств (Jan 2019)

VALIDATION OF METHODS OF QUANTITATIVE DETERMINATION LHS-1208 IN THE LYOPHILIZED DOSAGE FORM

  • I. D. Gulyakin,
  • L. L. Nikolaeva,
  • M. V. Dmitrieva,
  • N. A. Oborotova,
  • E. V. Ignatieva,
  • N. A. Dmitricheva,
  • I. V. Yartseva,
  • Z. S. Shprakh

Journal volume & issue
Vol. 0, no. 4
pp. 118 – 122

Abstract

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In order to ensure reliable and accurate results, the authors carried out the validation procedure developed technique for spectrophotometric quantification of the active substance for the lyophilized liposomal formulation of national hydrophobic antitumor compounds from the group of indolocarbazole - LHS-1208. As a result of the establishment of the specificity, linearity, range of use, accuracy and precision of a validated method may be used in the range of 80-120% concentration LHS-1208 in the dosage form.

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