DEVELOPMENT AND VALIDATION OF METHOD OF QUANTITATIVE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN INNOVATIVE ACTIVE PHARMACEUTICAL INGREDIENT WITH GC-FID
Abstract
The aim of the study was to develop and validate a new method of quantitative determination of residual organic solvents in a substance A using GLC. Studies were carried out with gas chromatography with a flame ionization detector and sampling from the vapor phase. The effect of the polarity of the stationary phase for the chromatographic separation of the organic solvents peaks: Chloroform, Ethanol, Methylene Chloride, Cyclohexane, Ethyl Acetate, Methanol, N, N-dimethylformamide, 2-propanol was investigated. Chromatographic separation of Ethanol, Methanol, 2-propanol, Ethyl Acetate, Methylene Chloride and Cyclohexane was performed with quartz capillary column DB-624, 30 m × 0.20 mm, 1.8 micron; Chloroform and N, N-dimethylformamide – DB-WAX, 30 m × 0.50 mm, 0.25 mm. System suitability criteria and the validity of method were determined. Method has high specificity, precision, linearity, sensitivity and reliability.
About the Authors
E. V. Butina
CJSC «BIOCAD»
Russian Federation
Russian Federation
S. A. Zaitsev
CJSC «BIOCAD»
Russian Federation
Russian Federation
A. V. Basevich
State Budgetary Educational Institution of Higher Professional Education «Saint-Petersburg state chemical-pharmaceutical Academy» of the Ministry of health of the Russian Federation
Russian Federation
Russian Federation
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Review
For citations:
Butina E.V., Zaitsev S.A., Basevich A.V. DEVELOPMENT AND VALIDATION OF METHOD OF QUANTITATIVE DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN INNOVATIVE ACTIVE PHARMACEUTICAL INGREDIENT WITH GC-FID. Drug development & registration. 2016;(4):124-128. (In Russ.)
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