Standartnye Obrazcy (May 2017)
Validation of analytical procedure for determination of recidual organic solvents for standardization the substance of 5,7-bis-meta-nitrophenylamino-4,6-dinitrobenzofuroxan
Abstract
The aim of this study was to develop and validate a gas chromatography methods of quantitative determination of residual organic solvents in substance of 5,7-bis-(meta-nitrophenylamino)-4,6-dinitrobenzofuroxan. Validation of elaborating methods of quantitative determination of residual organic solvents - ethyl alcohol and acetonitrile in substance of 5,7-bis-(meta-nitrophenylamino)-4,6-dinitrobenzofuroxan using gas chromatography method allowed to evaluate their metrology parameters. All parameters of validation characteristics met their acceptance criteria's. Specificity was demonstrated by a complete chromatographic separation of peaks of ethyl alcohol and acetonitrile, and lack of peaks of ethyl alcohol and acetonitrile in the chromatogram of solvent. The linearity was proven in the range of quantitation limit to 120 % of the test concentrations. Precision of the methods comply with the requirement defined - the relative standard deviation for of ethyl alcohol and acetonitrile below 3 %. The results of this validation study prove the suitability of the gas chromatography method for quantitative determination of residual organic solvents in substance of 5,7-bis-(meta-nitrophenylamino)-4,6-dinitrobenzofuroxan.
