| 杜超,罗舟,卓秋琪,唐云,李伟.HPLC测定醋酸阿比特龙的含量与有关物质[J].井冈山大学自然版,2021,42(3):25-30 |
| HPLC测定醋酸阿比特龙的含量与有关物质 |
| DETERMINATION OF ABITRON ACETATE AND ITS RELATED SUBSTANCES BY HPLC |
| 投稿时间：2020-12-20 修订日期：2021-02-08 |
| DOI：10.3669/j.issn.1674-8085.2021.03.006 |
| 中文关键词: 醋酸阿比特龙 HPLC 含量测定 有关物质 |
| 英文关键词: abiraterone acetate HPLC content determination related substances |
| 基金项目:江西省教育厅科技计划项目（GJJ190856）；膀胱癌靶向药物及新型制剂产业化开发项目（20180309162621813） |
| 作者 | 单位 | | 杜超 | 宜春学院化学与生物工程学院, 江西, 宜春 336000
深圳万乐药业有限公司, 广东, 深圳 518029 | | 罗舟 | 深圳万乐药业有限公司, 广东, 深圳 518029 | | 卓秋琪 | 深圳万乐药业有限公司, 广东, 深圳 518029 | | 唐云 | 宜春学院化学与生物工程学院, 江西, 宜春 336000 | | 李伟 | 宜春学院化学与生物工程学院, 江西, 宜春 336000 |
|
| 摘要点击次数: 2359 |
| 全文下载次数: 3253 |
| 中文摘要: |
| 本实验建立HPLC测定醋酸阿比特龙的含量与有关物质，为醋酸阿比特龙质量综合评价和控制提供参考。采用Eclipse plus C18（5 μm，4.6 mm×250 mm），流动相A：乙腈溶液（含2%异丙醇） B：0.01 mol/L的醋酸铵溶液，流速：1.0 mL/min，波长：254 nm，梯度洗脱。实验结果显示，其在0.3033~1.0111 mg/mL范围内，具有良好的线性关系，平均回收率为99.41%（RSD=1.10%），且能与有关物质可实现很好分离。在16 h内溶液稳定性良好，RSD=0.33%；定量限为0.97 ng，检测限为0.291 ng。该法简单、便捷、精准、灵敏度高，适用于醋酸阿比特龙含量与有关物质测定。 |
| 英文摘要: |
| A method for determination of the content and related substances of abiraterone acetate by HPLC was established to provide a reference for the comprehensive evaluation and control of the quality of abiraterone acetate. The column was Eclipse plus C18 (5 μm, 4.6×250 mm), the mobile phase A and B were acetonitrile solution (containing 2% isopropanol) and 0.01 mol/L ammonium acetate solution, respectively, the flow rate was 1.0 mL/min, and the wavelength was 254 nm, gradient elution was applied. The results showed that it had a good linear relationship in the range of 0.3033~1.0111 mg/mL, the average recovery rate was 99.41% (RSD=1.10%), and it could be separated from related substances well. The stability of the solution was good within 16 h, RSD=0.33%; the limit of quantification and detection were 0.97 ng and 0.291 ng, respectively. The method is simple, convenient, accurate and highly sensitive, and is suitable for the determination of abiraterone acetate content and related substances. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |
|
|
|
