高效液相色谱法测定右兰索拉唑含量及其异构体
Determination of dexlansoprazole and its isomers by HPLC
王伟姣 1李彩花 2唐敬亮 1罗晖明 1唐浩铮 1童明2
作者信息
- 1. 湖南省药品检验检测研究院,长沙 410001
- 2. 湖南欧亚药业有限公司,湖南 浏阳 410300
- 折叠
摘要
目的 建立高效液相色谱法测定右兰索拉唑含量及其异构体.方法 右兰索拉唑含量测定采用ZORBAX XDB-C18(4.6 mm × 250 mm,5 μm)色谱柱,以甲醇-水-三乙胺-磷酸(400∶600∶5∶1.5)[用磷酸溶液(1→ 10)调节pH值至7.3]∶甲醇(55∶45)为流动相.检测波长为284 nm;流速为1.0 mL·min-1;柱温30℃.右兰索拉唑异构体测定采用CHIRALCELOZ-3R(4.6 mm× 150 mm,3 μm)色谱柱,以 0.05 mol·L-1 磷酸二氢钠溶液-乙腈(60∶40)为流动相.结果 右兰索拉唑及其异构体的线性范围分别为73.2071～219.6214μg·mL-1(r=0.999 98)、0.5081～3.0485 μg·mL-1(r=0.999 99);右兰索拉唑低、中、高浓度的平均回收率分别为 98.9％(RSD=0.040％)、99.4％(RSD=0.42％)、98.7％(RSD=0.89％),异构体低、中、高浓度的平均回收率分别为103.6％(RSD=2.3％)、102.6％(RSD=2.1％)、100.8％(RSD=0.26％);检测限分别为 0.4928 μg·mL-1、0.2540 μg·mL-1;定量限分别为0.9856μg·mL-1、0.5081 μg·mL-1.结论 本方法准确度高、重复性好,可用于右兰索拉唑含量测定及其异构体检查.
Abstract
Objective To establish an HPLC method to determinate the content and isomers of dexlansoprazole.Methods For the content detection of dexlansoprazole,ZORBAX XDB-C18(4.6 mm × 250 mm,5 μm)was used with methanol-water-triethylamine-phosphate(400∶600∶5∶1.5)[adjusting pH to 7.3 with phosphoric acid solution(1 → 10)]:methanol(55:45)as the mobile phase,eluted at a flow rate of 1.0 mL·min-1.The column temperature maintained at 30 ℃ and the detection wavelength was set at 284 nm.For the detection of isomers,CHIRALCEL OZ-3R(4.6 mm × 150 mm,3 μm)was used with 0.05 mol·L-1 sodium dihydrogen phosphate solution-acetonitrile(60∶40)as the mobile phase.Results The calibration curve of dexlansoprazole and its isomers was linear at 73.2071～219.6214 μg·mL-1(r=0.999 98),and 0.5081～3.0485 μg·mL-1(r=0.999 99).The recoveries of dexlansoprazole at low,middle and high concentrations were 98.9％(RSD=0.040％),99.4％(RSD=0.42％)and 98.7％(RSD=0.89％),respectively.The recoveries of isomers at low,middle and high concentrations were 103.6％(RSD=2.3％),102.6％(RSD=2.1％)and 100.8％(RSD=0.26％),respectively.The limit of detection was 0.4928 μg·mL-1 and 0.2540 μg·mL-1;the limit of quantitative was 0.9856 μg·mL-1 and 0.5081μg·mL-1.Conclusion This method is specific and accurate for determination the content and its isomers in dexlansoprazole.
关键词
右兰索拉唑/高效液相色谱法/含量测定/异构体Key words
dexlansoprazole/HPLC/content determination/isomer引用本文复制引用
出版年
2024
NETL
NSTL
万方数据