Determination of 12 plasticizers residues in pharmaceutical composite films by gas chromatography-mass spectrometry
RAO Yanchun ZHU Bijun ZUO Junfeng CHANG Liang
Jiangxi Institute for Drug Control Key Laboratory of Quality Evaluation of Chinese Patent Medicine,
National Medical Products Administration Jiangxi Province Engineering Research Center of Drug and Medical Device Quality, Jiangxi Province, Nanchang 330029, China
Abstract：Objective To establish a gas chromatography-mass spectrometry (GC-MS) method for the determination of 12 plasticizers residues in pharmaceutical composite films. Methods The samples were extracted with n-hexane ultrasound and detected by GC-MS. The gas chromatography was performed on a HP-5 MS capillary column (30 m×0.25 mm×0.25 μm). The program was heated up, the inlet temperature was 290℃, and an electron bombardment (EI) ion source was used in the mass spectrometry to detect under the selected ion monitoring mode. The ion source temperature was 280℃ and the quadrupole temperature was 150℃. Results The values of correlation coefficient r of the 12 plasticizer standard curves were greater than 0.998, the average recovery was 78.6%-110.9%, RSD ≤ 4.0% (n = 9). Conclusion This method has good accuracy and high sensitivity, which can be used for the detection of plasticizers residues in pharmaceutical composite films.
2020, Vol. 17 
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