消旋体出峰顺序对酮洛芬中微量对映异构体杂质测定的影响及市售右旋酮洛芬制剂的对映体纯度评价。

Department of Forensic Toxicology, Institute of Forensic Sciences, Ankara University, Ankara 06590, Turkey.

Institute of Physical and Analytical Chemistry, School of Exact and Natural Sciences, Tbilisi State University, Chavchavadze Ave 3, 0179 Tbilisi, Georgia.

Molecules. 2020 Dec 11;25(24):5865. doi: 10.3390/molecules25245865.

In a recent study, opposite enantiomer elution order was observed for ketoprofen enantiomers on two amylose-phenylcarbamate-based chiral columns with the same chemical composition of the chiral selector but in one case with coated while in the other with an immobilized chiral selector. In the present study, the influence of this uncommon effect on method validation parameters for the determination of minor enantiomeric impurity in dexketoprofen was studied. The validated methods with two alternative elution orders for enantiomers were applied for the evaluation of enantiomeric impurity in six marketed dexketoprofen formulations from various vendors. In most of these formulations except one the content of enantiomeric impurity exceeded 0.1% (/).

在最近的一项研究中，两种基于直链淀粉-苯甲酰氨基甲酸酯的手性柱对酮洛芬对映异构体表现出相反的对映体洗脱顺序，这两种手性柱的手性选择剂具有相同的化学组成，但在一种情况下是涂敷的，而在另一种情况下是固定的。在本研究中，研究了这种不常见的效应对手性杂质对映体在右旋酮洛芬中微量测定的方法验证参数的影响。使用两种替代的对映体洗脱顺序验证的方法，用于评估来自不同供应商的六种市售右旋酮洛芬制剂中的对映体杂质。在这些制剂中，除了一种之外，大多数制剂的对映体杂质含量超过 0.1% (/ )。