少是多:验证一个单一的方法来进行全面的rh-胰岛素分析
Sanjay Mendiratta1, Gurminder Bindra1, Sukhwinder Singh1
1National Institute of Biologicals, Ministry of Health and Family welfare, Noida 201309, India.
Journal of pharmaceutical and biomedical analysis
|March 28, 2024
概括
一种新的单反相高性能液态色谱 (RP-HPLC) 方法准确地分析人体胰岛素效能和相关蛋白质. 这种简化方法减少了质量控制的分析时间和成本.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 印度药典中人类胰岛素分析的当前方法涉及对强度和相关蛋白质的单独程序.
- 这需要多次分析运行,增加质量控制的时间和资源支出.
研究的目的:
- 开发和验证一种单一的统一方法,用于同时分析人体胰岛素效能和相关蛋白质.
- 为胰岛素配方建立一个更有效,更具成本效益的质量控制过程.
主要方法:
- 使用了C-18静止相的反相高性能液态染色学 (RP-HPLC).
- 采用了55%缓冲剂 (0.2M硫酸,pH2.3) 和45%乙二的移动相,可在214nm处检测紫外线.
- 验证了该方法的线性,准确性和检测极限.
主要成果:
- 该方法在0.08-4.5 mg/mL (r2=0.999) 的度范围内显示出出色的线性.
- 达到0.094mg/ml的检测极限,准确度在99%到102.8%之间.
- 在单次色谱运行中成功量化了强度和相关蛋白质.
结论:
- 一个单一的RP-HPLC方法提供了一个精确而有效的手段,可以同时分析人体胰岛素效能和相关蛋白质.
- 这种统一的方法在制造和监管环境中为质量分析节省时间和成本方面提供了显著的优势.
- 这种方法的实施可以提高用于公共卫生的标准化,高质量的胰岛素制剂的可用性.
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