通过在多维生素与矿物质囊中的超高性能液体染色学同时确定10种脂溶性维生素
Salika Jeelani1, Zarema Kassymbek1
1Analytical Development Laboratory, United States Pharmacopeial Convention (USP), Rockville, Maryland, USA.
Journal of separation science
|May 22, 2025
概括
一种新的超高性能液态染色法 (UHPLC) 方法可以准确地确定多维生素囊中的10种脂溶性维生素. 这种经过验证的方法提供了更简单的样品制备和可靠的质量控制结果.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 准确量化脂肪溶性维生素对于多维生素产品的质量至关重要.
- 在像囊这样的复杂矩阵中分析维生素的现有方法可能是耗时和复杂的.
研究的目的:
- 开发和验证一种新,准确和高效的UHPLC-UV方法,用于同时确定10种脂溶性维生素.
- 建立一个简化的样品制备技术,用于多维生素囊.
主要方法:
- 具有紫外线检测的超高性能液态染色学 (UHPLC).
- 在Waters XBridge Shield C18柱上进行分离,其中有一种梯度移动相 (0.1%的酸在水和酸中).
- 样品的制备,包括酶消化和超声波.
主要成果:
- 同时确定了10种脂溶性维生素.
- 优秀的线性 (R2>0.999),精度 (RSD<5%) 和准确性 (99.2%-101.9%的恢复).
- 方法验证证实了根据ICH指南的适用性.
结论:
- 开发的UHPLC方法对于分析多维生素囊中的脂溶性维生素是准确,精确和高效的.
- 简化样品制备提高了该方法的实用性.
- 该方法适合潜在的纳入USP-NF多维生素与矿物质囊专著.
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