紫外-可见分光光度法测定穿心莲内酯磺化物注射液中总磺化物的含量

Determination of Total Sulfonate in Androgrspholide Sulfonate Injection by UV Visible Spectrophotometry

关键词:  穿心莲内酯  总磺化物  含量测定  紫外-可见分光光度法

Key words:  Andrographolide  total sulfonate  content determination  UV-Visible Spectrophotometry

摘要:

穿心莲内酯磺化物注射液总磺化物含量测定方法学考察。以穿心莲内酯为对照品，以1%间二硝基苯乙醇溶液为参比溶液，照紫外-可见分光光度法(《中国兽药典》2020年版二部 附录0401)在407 nm波长处进行标准曲线制备，测定供试品浓度并计算其含量。穿心莲内酯质量浓度在0.48~0.8 mg/mL范围内与吸光度线性关系良好，回归方程为y=0.0016x-0.5122（R2=0.9993）；该测定方法经考察表明具有良好的精密度、重复性、稳定性和准确度，平均加样回收率为100.03%，RSD为1.23%(n=6)；10批产品中总磺化物平均含量为24.86 mg/mL。本测定方法基于二萜类化合物结构与光吸收特性关系而建立，重现性好，准确度高，适用于本产品中总磺化物的含量测定。

Abstract:

To investigate the methodology for determining the total sulfonate content Andrographolide Sulfonate Injection. Using andrographolide as the reference standard and 1% m-dinitrobenzene ethanol solution as the reference solution, a standard curve was prepared at a wavelength of 407 nm according to the UV-Visible Spectrophotometry method (Appendix 0401, Volume II, 2020 Edition of the Chinese Veterinary Pharmacopoeia). The concentration of the test sample was measured and its content calculated. Results: The mass concentration of andrographolide showed a good linear relationship with absorbance in the range of 0.48 mg/mL to 0.8 mg/mL, with a regression equation of y=0.0016x-0.5122 (R2=0.9993). The method demonstrated good precision, repeatability, stability, and accuracy, with an average spiked recovery rate of 10003% and an RSD of 1.23% (n=6). The average total sulfonate content in 10 batches of products was 2486 mg/mL. This method, based on the relationship between the structure of diterpenoids and their light absorption characteristics, exhibits good reproducibility and high accuracy, making it suitable for determining the total sulfonate content in this product.