目的：对盐酸羟苄唑原料中的有关物质进行分析，分析其杂质来源。方法：采用HPLC-TOF-MS法。色谱柱为Zorbax XDB C18（4.6 mm ×150 mm，5μm），流动相为甲醇-乙腈-醋酸铵缓冲液（pH 4.0）（20∶10∶70），流量1.0 mL· min－1，检测波长277 nm；采用电喷雾离子源（ ESI ），离子源温度为120℃，正／负离子扫描检测，一级全扫描及二级扫描测定，质量扫描范围m／z 100～1200。结果：初步分析有两个主要杂质，并推测其结构及来源。结论：本方法的分析结果，可为盐酸羟苄唑原料质量标准提高提供重要依据，并为其质量控制提供保障。%Objective: To analyzethe related substances of Hydrobenzole Hydrochloride and the source of impurity.Methods: An HPLC-TOF-MS method was adopted.The assay was performed on a Zorbax XDB C 18 column (4.6 mm ×150 mm, 5 μm) with a mo-bile phase of methanol-acetonitrile-ammonium acetate buffer (pH 4.0) (20∶10∶70) at a flow rate of 1.0 mL· min-1, the detection wavelength was 277 nm.The full scan and two stage scanning was employed for detection with ESI source inpositive /negative ion mode.the source temperature was 120℃, and mass scan range was m/z 100-1 200.Results:Two main impurities were analyzed prelimina-rily, the structures and origins were speculated.Conclusion:The results of analysis can provide an important basis for improving the quality standards and protection for their quality control.
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