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| Analysis of Nonvolatile Extractables in Pharmaceutical Packaging Materials in Buffered Saline Based on Polymer Additive Library |
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| DOI： |
| KeyWord:nonvolatile extractables pharmaceutical packaging material ultra performance liquid chromatography tandem quadrupole-time-of-flight mass spectrometry(UPLC-QTOF-MS) library searching |
| Author | Institution |
| XING Xue-bin,ZHANG Yun,SUN Shu-qi,DU Zhen-xia*,QIN Sun-xing*,DONG Yan |
1.北京化工大学理学院;2.上海乐纯生物技术有限公司 |
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| Abstract: |
| A rapid method for the determination of extractables in pharmaceutical packaging materials was developed by ultra-performance liquid chromatography-quadrupole time-of-flight-mass spectrometry(UPLC-QTOF-MS) based on UNIFI software and a polymer additive library.The samples were extracted with chloroform,and then the extractables were separated on a CORTECS C18(2.1mm×100mm,1.6μm) column using a binary solvent system composed of methanol and 0.1% formic acid water solution. Screening and quantitative analysis were accomplished by UPLC-QTOF-MS under positive electrospray ion mode.The results showed that four extractables were detected in buffered saline(25℃,60 days).Diisodecyl phthalate(DIDP) was identified by library searching and quantitated by external standard method with a concentration of 1.98 μg/L.The other three extractables were inferred and identified by accurate mass and MSE spectra match,and they were quantitated with dicyclohexyl phthalate(DCHP).The total content of the three compounds was 10.80μg/L.The recovery analysis was carried out to evaluate the method with DIDP.The results indicated that the recoveries of DIDP ranged from 90.1% to 97.1% with relative standard deviation(RSD) no more than 3.7%(n=6) at three spiked concentration levels(5,10,20μg/L).The method was rapid, accurate and sensitive,and was suitable for the safety investigation on pharmaceutical packaging materials. |
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