| Study on HPLC Analysis of Zinc Dibutyldithiocarbamate in Pharmaceutical Rubber Stoppers |
| Received:November 12, 2021 Revised:November 12, 2021 |
| DOI：10.12136/j.issn.1000-890X.2022.07.0547 |
| Key Words: pharmaceutical rubber stopper；zinc dibutyldithiocarbamate；HPLC；metal chelates |
| Author Name | Affiliation | E-mail | | XIE Langui* | National Institutes for Food and Drug Control；NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients | pharm215@126.com | | YUAN Shusheng | National Institutes for Food and Drug Control；NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients | | | HAN Xiaoxu | National Institutes for Food and Drug Control；NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients | | | YANG Huiying | National Institutes for Food and Drug Control；NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients | | | ZHAO Xia | National Institutes for Food and Drug Control；NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients | | | XIAO Xinyue | National Institutes for Food and Drug Control；NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients | |
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| Abstract: |
| A high-performance liquid chromatography（ HPLC） method was established to determine the residual amount of zinc dibutyldithiocarbamate in pharmaceutical rubber stoppers.The pharmaceutical rubber stopper was pulverized after being embrittled in liquid nitrogen，and then it was ultrasonically extracted with tetrahydrofuran-acetonitrile（ volume ratio of 10 ∶ 90） to prepare a test solution.The tetrahydrofuran-acetonitrile（volume ratio of 35∶ 65） was used as the mobile phase，after passing through SunFire C18 chromatographic column（4. 6 mm×250 mm， 5 μm） for separation， the test solution was tested by HPLC with the detection wavelength of 254 nm.The results showed that the mass concentration of zinc dibutyldithiocarbamate in 20～750 μg·mL-1 had a good linearity correlation with the HPLC peak area，the correlation coefficient was 0. 999 9.The relative standard deviations of HPLC peak area of the test solutions with high， medium and low concentration were less than 3%，and the test precision was high.The detection limit and quantification limit of this test were 20 and 30 ng respectively，the recovery rate was 98. 84% ～ 102.58%，and the test solution was stable within 6 h.This method established in this paper was simple，accurate，sensitive，stable，and it was suitable for the determination of the residual amount of zinc dibutyldithiocarbamate in pharmaceutical rubber stoppers. |
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