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周羽晗,等:高效液相色谱法同时测定医用敷料类医疗器械产品中17种对羟基苯甲酸酯类化合物的含量


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                       Simultaneous Determination of 17 Hydroxybenzoate Compounds in

                              Medical Dressing Category Medical Device Products by
                                     High Performance Liquid Chromatography


                   ZHOU Yuhan , YUAN Rongsui , DUAN Yulin , BIAN Hedong , ZHANG Yuzhen , WEI Jiarong ,
                                1
                                               2
                                                                          1
                                                                                           1
                                                                                                        3
                                                            2
                                                LU Lanjuan , JIANG Shoujun 2*
                                                           3
                     (1. School of Chemistry and Chemical Engineering, Guangxi University for Nationalities, Nanning 530006, China;
                    2. Guangxi Zhuang Autonomous Region Food and Drug Evaluation and Inspection Center, Nanning 530029, China;
                                  3. Guangxi Minsheng Sino Assessment Group Co., Ltd., Nanning 530007, China)
                  Abstract: After adding the mixed solution of methanol and acetonitrile at volume ratio of 8∶2 into samples of medical
              dressing category medical device products, vortex mixing, ultrasonic extraction, and centrifugal separation were performed.
              The supernatant was passed through a 0. 22 μm filter membrane, and the filtrate was introduced into the high performance liquid
              chromatograph. Hydroxybenzoate compounds (PBs) were separated by gradient elution with mixed solutions of acetonitrile and
              0. 12% (volume fraction) phosphoric acid solution at different volume ratios on the ShimNex CS C 18  column, and quantified
              by the external standard method. It was shown that linear relationships between values of mass concentration and peak area of
                                                 −1                                            −1
              17 PBs were kept in the range of 1-50 mg · L  , with detection limits (3S/N) in the range of 5-18 mg · kg  .  Test for recovery
              was made according to the standard addition method, giving recoveries in the range of 97. 6%-108%, and RSDs (n=6) of the
              determined values ranged from 0. 30% to 4. 4%. This method was used to screen 10 batches of actual samples with different
              matrices, and the detection rate of PBs was 40%. Methyl p-hydroxybenzoate was detected in 1 batch of samples, and ethyl p-

              hydroxybenzoate and propyl p-hydroxybenzoate were detected in 3 batches of samples.
                  Keywords:  medical  dressing  category  medical  device  product;  hydroxybenzoate  compound;  high  performance  liquid
              chromatography; determination




























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