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高效液相色谱法测定对氯苯氧异丁酸甲氧基苯丙烯酸酯胶囊含量及有关物质
高效液相色谱法测定对氯苯氧异丁酸甲氧基苯丙烯酸酯胶囊含量及有关物质
张 婷1,彭 红1,金 鑫1,肖 飞1,陈淑娴2

1 江西中医药大学,南昌 330004;2 中国药科大学,南京 210000
HPLC determination of the contents of (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid and related substances in its capsules
(1 Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China;2 China Pharmaceutical University, Nanjing 210000, China)

摘要参考文献相关文章

起始页:2854

摘要:目的:采用HPLC法测定对氯苯氧异丁酸甲氧基苯丙烯酸酯胶囊的含量及其有关物质。方法:含量测定采用Eclipse XDB-C18(150 mm×4.6 mm,5 μm)为色谱柱,流动相使用甲醇-1%醋酸水(80∶20),检测波长为275 nm,流速为1.0 mL·min-1;柱温为25 ℃。有关物质测定采用Eclipse XDB-C18(150 mm×4.6 mm,5 μm)为色谱柱,以甲醇-1%醋酸(70∶30)作为流动相,检测波长为275 nm,流速为1.0 mL·min-1,柱温为25 ℃。结果:氯苯氧异丁酸甲氧基苯丙烯酸酯10.1~100.8 μg·mL-1范围内线性关系良好(A=52.884C+29.705,r=0.999 8)。重复性良好(RSD=0.35%),进样的精密度高,稳定性好。平均回收率为102.1%,RSD值为0.56%,氯苯氧异丁酸甲氧基苯丙烯酸酯与有关物质分离度良好,且空白辅料不干扰检测。结论:本方法操作简便,准确度高,专属性好,适用于对氯苯氧异丁酸甲氧基苯丙烯酸酯的含量及有关物质测定。

关键词:HPLC法;对氯苯氧异丁酸甲氧基苯丙烯酸酯胶囊;含量测定;有关物质

通讯作者:彭红,女,硕导,教授,主要从事药物质量控制研究。

基金项目:

作者简介:

Abstract:Objective: To develop a high performance liquid chromatography (HPLC) method for determining the contents of (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid and the related substances in its capsules. Methods: Eclipse XDB-C18 column (150 mm×4.6 mm, 5 μm) was used for the determination of (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid. The mobile phase was methanol-1% acetic acid (80∶20) at a flow rate of 1.0 mL·min-1. The detection wavelength was 275 nm and column temperature was 25 ℃. The same column was used for detecting the related substances with methanol-acetic acid (70∶30) as the mobile phase. The detection wavelength was 275 nm, the flow rate was 1.0 mL·min-1, and column temperature was 25 ℃.
Eclipse XDB-C18 column(150 mm×4.6 mm, 5 μm) was used for detecting the related substances with methanol-acetic acid water(70∶30) as the mobile phase.
Results: The calibration curve of (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid was linear in the range of 10.1 to 100.8 μg·mL-1 (A=52.884C+29.705, r=0.999 8). Repeatability was good (RSD=0.35%). Average recovery of (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid was 102.1%(RSD=1.68%), (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid and its related substances were completely separated(E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid and its related substances were completely separated,and blank accessories do not interfere with the detection. Conclusion: The method is simple and accurate with good reproducibility, which can be used for the determination of (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid and related substances in its capsules.

Key words:HPLC; (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid capsules; determination; related substances

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