| 金昭,刘志海,彭啟丽,王丹丹.UPLC法测定消炎止咳胶囊中的穿心莲内酯和脱水穿心莲内酯的含量[J].,2025,34(1):49-52 |
| UPLC法测定消炎止咳胶囊中的穿心莲内酯和脱水穿心莲内酯的含量 |
| Determination of Andrographolide and Dehyandrographolide in Xiaoyan Zhike CapsuLes by UPLC Method |
| 投稿时间：2024-04-16 |
| DOI： |
| 中文关键词: 消炎止咳胶囊 穿心莲 穿心莲内酯 脱水穿心莲内酯 UPLC |
| 英文关键词: Xiaoyan Zhike Capsules Andrographis PanicuLata Andrographolide Dehyandrographolide UPLC |
| 基金项目:贵州省药品监督管理局，《贵州省2022年度省级药品探索性研究课题》 |
|
| 摘要点击次数: 433 |
| 全文下载次数: 0 |
| 中文摘要: |
| 目的：建立消炎止咳胶囊中穿心莲内酯和脱水穿心莲内酯的超高效液相色谱（ultra performance liquidchromatography，UPLC)含量测定方法，提高该制剂质量控制标准。方法：采用UPLC含量测定方法。色谱条件：BEH C18(2.1mm×150mm，1.7um)为分离柱；流动相为乙腈-水，梯度洗脱；穿心莲内酯检测波长为225nm，脱水穿心莲内酯检测波长为254nm；柱温为30℃；流速0.3mL/min，进样体积2μL。结果：穿心莲内酯在13.0775~130.7748μg/mL范围内呈良好的线性关系（R2=0.9999，n=5）；加样回收率为97.4%，RSD值为1.3%。脱水穿心莲内酯在12.47129~124.7129μg/mL范围内呈良好的线性关系（R2=0.9999，n=5）；加样回收率为102.3%，RSD值为1.2%。对10批消炎止咳胶囊进行含量测定，穿心莲内酯含量测定结果为2442.34~2683.48μg/g，脱水穿心莲内酯的含量测定结果为1551.43~1834.64μg/g，二者的总含量测定结果为3995.91~4672.18μg/g。结论：采用UPLC对消炎止咳胶囊中的穿心莲内酯和脱水穿心莲内酯的成分进行含量测定，该方法专属性强、重复性好、简单高效、准确可靠，可用于该制剂的质量控制。 |
| 英文摘要: |
| Objective To establish a Ultra Performance Liquid Chromatography (UPLC) method for the determination of androgra-pholide and dehyandrographolide in Xiaoyan Zhike Capsules, and enhance the quality control standard of the preparation. MethodsThe UPLC content determination method was used. Chromatographic conditions: BEH Cs (2.1 mm × 150 mm, 1.7 um) was used asthe separation column; the mobile phase was acetonitrile – water with gradient elution; the detection wavelength of andrographolide was225 nm, and the detection wavelength of dehyandrographolide was 254 nm; the column temperature was 30 ℃ ; the flow rate was 0.3ml/min, and the injection volume was 2 u.L. Results Andrographolide The linear range was 13. 0775 - 130. 7748 ug/mL (R2 =0. 9999, n =5) , and the spiked recoveries were 97. 4% with the RSD value of 1. 3%. Dehyandrographolide showed good linear rela-tionship within the range of 12. 47129 - 124. 7129 ug/mL (R2 =0. 9999, n =5) ; the spiked recoveries were 102. 3% and the RSDvalue was 1.2%. The content of 10 batches of Xiaoyan Zhike Capsules was determined, and the results of andrographolide were2442. 34 –2683. 48 ug/g, the results of dehydrated dehyandrographolide were 1551. 43 – 1834. 64 ug/g, and the results of the totalcontent of the two were 3995. 91 –4672. 18 ug/g. Conclusion UPLC was used for the content determination of andrographolide anddehyandrographolide in Xiaoyan Zhike Capsules. The method is exclusive, reproducible, simple, efficient, accurate and reliable, andcan be used for the quality control of this preparation. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
|
|
|
