高效液相色谱法拆分并测定盐酸索他洛尔对映异构体

doi:10.19803/j.1672-8629.20240242

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (8): 888-891.
DOI: 10.19803/j.1672-8629.20240242

高效液相色谱法拆分并测定盐酸索他洛尔对映异构体

胡浩然¹, 张磊², 郑磊^1,*

¹山东省立第三医院医务部,山东济南 250031;
²临沂市检验检测中心,山东临沂 276001

收稿日期:2024-04-18 出版日期:2024-08-15 发布日期:2024-08-21
通讯作者: ^*郑磊,男,硕士,副主任药师,临床药学与药物分析。E-mail: zhenglei8501@163.com
作者简介:胡浩然,女,硕士,副主任医师,医务与药事管理。
基金资助:
山东省自然科学基金资助项目（ZR2022MH250）; 山东省医学会临床科研资金（YXH2022ZX02050）

Chiral separation and content determination of sotalol hydrochloride by HPLC

HU Haoran¹, ZHANG Lei², ZHENG Lei^1,*

¹Medical Department of Shandong Provincial Third Hospital, Jinan Shandong 250031, China;
²Linyi Inspection and Testing Center, Linyi Shandong 276001, China

Received:2024-04-18 Online:2024-08-15 Published:2024-08-21

摘要/Abstract

摘要： 目的建立高效液相色谱法拆分并测定盐酸索他洛尔对映异构体的含量。方法采用CHIRALPAK AD-H手性固定相色谱柱（5 μm,250 mm×4.6 mm）,流动相为正己烷-乙醇（80︰20）,等度洗脱,检测波长为225 nm,流速为1.0 mL·min^-1,柱温为25℃,进样量为10 μL。结果盐酸索他洛尔2种对映异构体分离度良好,2个色谱峰之间的分离度大于2.0,2种对映异构体在1.005~100.5 μg·mL^-1和1.073~107.3 μg·mL^-1的浓度范围内线性关系良好（r=0.999）,平均回收率分别为97.05%[相对标准偏差（RSD）=2.26%]、98.24%（RSD=2.80%）。2种异构体的检测限均为0.1 μg·mL^-1,定量限均为0.3 μg·mL^-1,精密度试验、重复性试验与稳定性试验均良好。结论所建立的方法准确可靠,灵敏度高,可用于盐酸索他洛尔对映异构体的拆分与含量测定。

关键词: 盐酸索他洛尔, 对映异构体, 高效液相色谱法, 手性拆分, 含量测定

Abstract: Objective To separate and determine the content of sotalol hydrochloride by HPLC. Methods A CHIRALPAK AD-H chiral phase column (5 μm, 250 mm×4.6 mm) was used, with a mobile phase of n-hexane-ethanol (80∶20), at the flow rate of 1.0 mL·min^-1. The detection wavelength was 225 nm, the column temperature 25 ℃, and the injection volume was 10 μL. Results The two enantiomers were well separated, and the resolution between the peaks of the two enantiomers exceeded 2.0. The linearity between the two enantiomers was good within the range of 1.005~100.5 μg·mL^-1 (r=0.999) and 1.073~107.3 μg·mL^-1 (r=0.999), respectively. The average recovery of the two enantiomers was 97.05% and 98.24% respectively, with an RSD of 2.26% and 2.80%, respectively. The detection limit of the two enantiomers was 0.1 μg·mL^-1, and the quantification limit was 0.3 μg·mL^-1. The precision test, repeatability test, and stability test proceeded well. Conclusion The established method is accurate and reliable, which can be used in chiral separation and content determination of sotalol hydrochloride.

Key words: sotalol hydrochloride, enantiomer, HPLC, chiral separation, content determination

中图分类号:

R927.2

胡浩然, 张磊, 郑磊. 高效液相色谱法拆分并测定盐酸索他洛尔对映异构体[J]. 中国药物警戒, 2024, 21(8): 888-891.

HU Haoran, ZHANG Lei, ZHENG Lei. Chiral separation and content determination of sotalol hydrochloride by HPLC[J]. Chinese Journal of Pharmacovigilance, 2024, 21(8): 888-891.

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高效液相色谱法拆分并测定盐酸索他洛尔对映异构体

Chiral separation and content determination of sotalol hydrochloride by HPLC

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