DEVELOPMENT AND VALIDATION THE METHOD OF QUANTITATIVE DETERMINATION OF ETORICOXIB IN SOLID PHARMACEUTICAL FORMS BY HPLC
Abstract
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.
About the Authors
T. L. Batalova
State Institute of Drugs and Good Practices, the Ministry of Industry and Trade of the Russian Federation
Russian Federation
Russian Federation
O. A. Ostapyuk
State Institute of Drugs and Good Practices, the Ministry of Industry and Trade of the Russian Federation
Russian Federation
Russian Federation
K. R. Saveleva
State Institute of Drugs and Good Practices, the Ministry of Industry and Trade of the Russian Federation
Russian Federation
Russian Federation
T. Y. Andreevicheva
State Institute of Drugs and Good Practices, the Ministry of Industry and Trade of the Russian Federation
Russian Federation
Russian Federation
L. V. Persanova
State Institute of Drugs and Good Practices, the Ministry of Industry and Trade of the Russian Federation
Russian Federation
Russian Federation
S. V. Polyakov
State Institute of Drugs and Good Practices, the Ministry of Industry and Trade of the Russian Federation
Russian Federation
Russian Federation
V. N. Shestakov
State Institute of Drugs and Good Practices, the Ministry of Industry and Trade of the Russian Federation
Russian Federation
Russian Federation
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Review
For citations:
Batalova T.L., Ostapyuk O.A., Saveleva K.R., Andreevicheva T.Y., Persanova L.V., Polyakov S.V., Shestakov V.N. DEVELOPMENT AND VALIDATION THE METHOD OF QUANTITATIVE DETERMINATION OF ETORICOXIB IN SOLID PHARMACEUTICAL FORMS BY HPLC. Drug development & registration. 2018;(1):90-95. (In Russ.)
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