摘要
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 C_(18)(4.6 mm×150 mm,5μm),流动相为甲醇-乙腈-醋酸铵缓冲液(p H 4.0)(20∶10∶70),流量1.0 m L·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 100~1 200。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.
出处
《中国药品标准》
CAS
2016年第3期189-193,共5页
Drug Standards of China
