Determination of 6 Residual Solvents in Vitamin B6 Injection by Gas Chromatography
Objective:To establish a head space gas chromatography method for simultaneous determination of residual organic solvents including ethanol,acetone,isobutyraldehyde,butyraldehyde,benzene,and toluene in VitaminB6 injection,analyze and evaluate the residual solvents in 255 batches of vitamin B6 injection from 45 pharmaceutical production enterprises.Methods:Using Angilent DB-624 capillary chromatography column;The detector was a FID detector;Program heating up;The temperature of the test sample flow path was 200 ℃;Transmission line temperature was 210 ℃;Detector temperature was 300 ℃;head space injection equilibrium temperature was 80 C;The head space injection equilibrium time was 45 minutes.Results:The chromatographic peak separation of the six residual solvents measured meets the requirements,The linear relationship of ethanol,acetone,isobutyraldehyde,butyraldehyde,benzene,and toluene were good(r≥0.9957);The recovery rate ranged from 90.4％to 103.7％;The quantification limit was 4.2 ng/mL to 2110.4 ng/mL,and the detection limit was 1.3 ng/mL to 633.1 ng/mL.No toluene was detected in the 255 batches of test samples.Some production enterprises only detected one residual solvent,while others detected five residual solvents,all of which were far below the prescribed limit.Conclusion:This method has high specificity,good repeatability,and high accuracy,and can be used for the detection of ethanol,acetone,isobutyraldehyde,butyraldehyde,benzene,and toluene in Vitamin B6 injection.
vitamin B6 injectionresidual solventshead space gas chromatography
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