| 引用本文: | 林琼,杨伟峰,陈爽.依巴斯汀原料药及其片剂有关物质测定方法的改进[J].中国现代应用药学,2015,32(4):489-492. |
| LIN Qiong,YANG Weifeng,CHEN Shuang.Improved Determination Method of Related Substances in Ebastine and Ebastine Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(4):489-492. |
|
| 摘要: |
| 目的 改进依巴斯汀原料药及其片剂有关物质的测定方法。方法 色谱柱采用YMC-pack ODS-A C18色谱柱(150 mm×4.6 mm，5 μm)，乙腈-磷酸盐缓冲液(pH 7.0)(75∶25)为流动相，柱温为35 ℃，流速为1.0 mL?min-1，检测波长为210 nm。结果 所建立色谱条件可有效检测出依巴斯汀原料药和片剂中杂质，杂质C和杂质D的检出限均为0.11 μg?mL-1，其校正因子均为1.4。结论 该方法测定依巴斯汀及其片剂有关物质简便、专属性强，测定结果准确可靠。 |
| 关键词: 依巴斯汀 有关物质 高效液相色谱法 杂质 |
| DOI： |
| 分类号: |
| 基金项目: |
|
| Improved Determination Method of Related Substances in Ebastine and Ebastine Tablets |
|
LIN Qiong1, YANG Weifeng1,2, CHEN Shuang2
|
|
1.Zhejiang University of Technology, Hangzhou 310014, China;2.Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China
|
| Abstract: |
| OBJECTIVE To improve the method of related substances determination of ebastine and ebastine tablets. METHODS Chromatography was carried on YMC-pack ODS-A C18 column (150 mm×4.6 mm, 5 μm) with the column temperature at 35 ℃, using the acetonitrile-phosphate buffer (pH 7.0) as the mobile phase at a flow rate of 1.0 mL?min-1. the detective wavelength was set at 210 nm. RESULTS The method was effective for determination of related substance in ebastine and ebastine tablets. The detection limit and the calibration factor both of impurity C and impurity D were 0.11 μg?mL-1 and 1.4 respectively. CONCLUSION The method proposed for determining the related substances determination of ebastine and ebastine tablets is quick, accurate and reliable. |
| Key words: ebastine related substance HPLC impurity |
