硫酸艾沙康唑原料药含量方法的研究

doi:10.19286/j.cnki.cci.2025.01.033

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摘要

建立了高效液相色谱法（HPLC）测定硫酸艾沙康唑原料药中硫酸艾沙康唑的含量。采用Agilent ZORBAX SB-Aq 4.6 mm×150 mm ，5μm色谱柱，流动相为乙腈-水-三氟乙酸（60∶40∶0.05），体积流量为1.0 mL/min，检测波长280 nm，柱温为35 ℃ ，进样量为15μL。通过光谱图、保留时间和峰面积参数对硫酸艾沙康唑进行定性、定量检测。硫酸艾沙康唑在0.03 ~ 0.28 mg/mL呈良好的线性关系（R2=0.999 8）；方法检测限为0.03 mg/mL，定量限为0.09 mg/mL，回收率为99.75% ~ 101.22%，精密度、重复性、稳定性完全满足检测需求。该方法快速、准确、分离度好，可快速检测硫酸艾沙康唑原料药中硫酸艾沙康唑的含量。

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关键词 ：高效液相色谱仪, 原料药, 硫酸艾沙康唑, 含量检测

Abstract：

In order to establish a high-performance liquid chromatography (HPLC) method for determining the content of esoconazole sulfate in the raw material of esoconazole sulfate, Agilent ZORBAX SB Aq 4.6 mm × 150 mm, 5 μm chromatographic column, mobile phase acetonitrile water trifluoroacetic acid (60∶40∶0.05), volumetric flow rate of 1.0 mL/min, detection wavelength of 280 nm, column temperature of 35 ℃, and injection volume of 15μL. Qualitative and quantitative detection of esoconazole sulfate using spectrogram, retention time, and peak area parameters were adopted. The linear relationship of esoconazole sulfate is good within the range of 0.03~0.28 mg/mL (R2=0.999 8); The detection limit of the method is 0.03 mg/mL, the quantification limit is 0.09 mg/mL, and the recovery rate is 99.75%~101.22%. The precision, repeatability, and stability fully meet the detection requirements. It was fast, accurate, and has good separation, and can quickly detect the content of esoconazole sulfate in the raw material of esoconazole sulfate.

Key words： Key words High performance liquid chromatography raw material drug esoconazole sulfate content detection

通讯作者: 姜鹏鹏（ 1989— ），男，河北景县人，高级工程师。

作者简介: 刘艳君（ 1995— ），女，河北晋州人，助理工程师。

引用本文:

刘艳君1,2，王丽霞1,2，梁丙辰1,2，郑小霞1,2，姜鹏鹏1,2，宋欣乳1,2，岳思琪1,2，张凤娜1,2. 硫酸艾沙康唑原料药含量方法的研究[J]. 煤炭与化工, 2025, 48(1): 156-160. Liu Yanjun1,2, Wang Lixia1,2, Liang Bingchen1,2, Zheng Xiaoxia1,2, Jiang Pengpeng1,2, Song Xinru1,2,. Research on the content method of oxaconazole sulfate API. CCI, 2025, 48(1): 156-160.

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