| 钱保勇,吴珺,赵慧.高效液相色谱法测定尿素中缩二脲和缩三脲的含量[J].中国药事,2022,36(5):541-547 |
| 高效液相色谱法测定尿素中缩二脲和缩三脲的含量 |
| Determination of Biuret and Triuret in Urea by HPLC |
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| DOI：10.16153/j.1002-7777.2022.05.008 |
| 中文关键词: 尿素 缩二脲 缩三脲 高效液相色谱法 药典 |
| 英文关键词: urea biuret triuret HPLC pharmacopoeia |
| 基金项目:2019年国家药典委员会标准提高项目(编号 2019H040) |
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| 中文摘要: |
| 目的： 建立了HPLC法测定尿素中缩二脲和缩三脲的含量方法： 采用Waters Atlantis T3色谱柱 (4.6 mm×250 mm，3.5μm)，以超纯水为流动相，流速为0.9 mL·min-1，测定波长为195 nm结果： 尿素、缩二脲和缩三脲之间的分离度均大于1.5，缩二脲和缩三脲在0.2~10µg·mL-1范围内线性关系良好 (r=1.000)，检测限和定量限分别为0.062µg·mL-1和0.206µg·mL-1。缩二脲和缩三脲的平均回收率分别为100.2%和102.2%，RSD分别为1.2%和0.9%(n=9)结论： 本方法准确、可靠、灵敏，可用于尿素中缩二脲和缩三脲的测定，作为2019年国家药典委员会标准提高项目，弥补了目前药典标准中尿素有关物质的研究空白。 |
| 英文摘要: |
| Objective: To establish an HPLC method for the determination of biuret and triuret in urea. Methods: Separation was performed by using a Waters Atlantis T3 column (4.6 mm×250 mm, 3.5 μm). The mobile phase was ultra-pure water at flow rate of 0.9 mL·min-1, and the detection wave length was 195 nm. Results: The resolutions among urea, biuret and triuret were more than 1.5. The linear relationship of biuret and triuret was good at a range of 0.2-10 µg·mL-1 (r=1.000). The limits of detection (LODs) and limits of quantificaion (LOQs) were 0.062 µg·mL-1 and 0.206 µg·mL-1. The average recovery of biuret and triuret were 100.2% and 102.2% with the RSD of 1.2% and 0.9% (n=9). Conclusion: The method is accurate, reliable and sensitive, and could be used for the determination of biuret and triuret in urea. As the standard improvement project of Chinese Pharmacopoeia Commissonin 2019, it makes up the research gap of urea-related substances in the current pharmacopoeia. |
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