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

Abstract

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.

About the Authors

I. D. Gulyakin
Federal State Budgetary Scientific Institution «N.N. Blokhin Russian Cancer Research Center»
Russian Federation


L. L. Nikolaeva
Federal State Budgetary Scientific Institution «N.N. Blokhin Russian Cancer Research Center»
Russian Federation


M. V. Dmitrieva
Federal State Budgetary Scientific Institution «N.N. Blokhin Russian Cancer Research Center»
Russian Federation


N. A. Oborotova
Federal State Budgetary Scientific Institution «N.N. Blokhin Russian Cancer Research Center»
Russian Federation


E. V. Ignatieva
Federal State Budgetary Scientific Institution «N.N. Blokhin Russian Cancer Research Center»
Russian Federation


N. A. Dmitricheva
Federal State Budgetary Scientific Institution «N.N. Blokhin Russian Cancer Research Center»
Russian Federation


I. V. Yartseva
Federal State Budgetary Scientific Institution «N.N. Blokhin Russian Cancer Research Center»
Russian Federation


Z. S. Shprakh
Federal State Budgetary Scientific Institution «N.N. Blokhin Russian Cancer Research Center»
Russian Federation


References

1. ОФС.1.2.1.1.0003.15 Спектрофотометрия в ультрафиолетовой и видимой областях // Государственная фармакопея, XIII изд.

2. ОФС 1.1.0012.15 Валидация аналитических методик // Государственная фармакопея, XIII изд.


Review

For citations:


Gulyakin I.D., Nikolaeva L.L., Dmitrieva M.V., Oborotova N.A., Ignatieva E.V., Dmitricheva N.A., Yartseva I.V., Shprakh Z.S. VALIDATION OF METHODS OF QUANTITATIVE DETERMINATION LHS-1208 IN THE LYOPHILIZED DOSAGE FORM. Drug development & registration. 2016;(4):118-122. (In Russ.)

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ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)