| 苑洪忠,赵凯,于文国,王伟杰.GC法测定二羟二丁基醚原料及其软胶囊的含量和有关物质[J].中国药品标准,2016,17(3):193-198 |
| GC法测定二羟二丁基醚原料及其软胶囊的含量和有关物质 |
| GC Determination and Related Substances in Dihydroxydibutylether Bulk Drug and Soft Capsules |
| 投稿时间：2016-02-02 修订日期：2016-03-25 |
| DOI： |
| 中文关键词: 气相色谱法 二羟二丁基醚原料及其软胶囊 有关物质 含量测定 |
| 英文关键词: GC Dihydroxydibutylether bulk drug and soft capsules related substance determination |
| 基金项目:石家庄市科技孵化计划项目 |
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| 摘要点击次数: 568 |
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| 中文摘要: |
| 目的：建立二羟二丁基醚原料及其软胶囊的有关物质和其组分Ⅰ、Ⅱ、Ⅲ含量测定的方法。方法：采用FFAP 型毛细管色谱柱，分流比为1 : 5，FID检测器，进样口温度250℃，检测器温度280℃，进样量1μl，程序升温。以正辛醇作为内标物，测定二羟二丁基醚有关物质及组分Ⅰ、Ⅱ、Ⅲ含量。结果：试验显示组分Ⅰ、Ⅱ、Ⅲ的回归方程分别为Y=0.031X+0.003、Y=0.033X+0.016、Y=0.036X+0.002，相关系数分别为0.9985、0.9985、0.9989，分别在0.19~6.30、0.88~28.89、0.33~10.81mg?ml-1浓度范围内与其峰面积呈良好线性关系。结论：本法可适用于二羟二丁基醚原料及其软胶囊组分Ⅰ、Ⅱ、Ⅲ的含量和有关物质测定。 |
| 英文摘要: |
| Objective: To establish a GC method for the determination of component Ⅰ, Ⅱ, Ⅲ and related substances in Dihydroxydibutylether bulk drug and soft capsules . Method: The determination was performed on a FFAP capillary column at the split ratio 1:5 with n-octyl alcohol as internal standard substance, the ?injection port temperature and the detector temperature were controlled at 250℃ and 280℃, the sample size was 1μl and the column temperature was programmed. Results: The calibration curve of component Ⅰ， Ⅱ and Ⅲ was linear in the range of 0.19~6.30，0.88~28.89 and 0.33~10.81mg?ml-1, respectively. The regression equation of componentⅠ,Ⅱand Ⅲ was Y=0.031X 0.003, Y=0.033X 0.016 and Y=0.036X 0.002 with RSD of 0.9985,0.9985 and 0.9989 ,respectively.Conclusion: The established method is suitable for the determination of component Ⅰ, Ⅱ, Ⅲ and related substances in Dihydroxydibutylether bulk drug and soft capsules. |
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