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LC-MS法检测国产盐酸贝那普利片中有关物质的研究

梁爱仙,庞发根,陈承贵,蔡锦雄,李玉兰   

  1. 深圳市药品检验研究院,深圳市药品检验研究院,深圳市药品检验研究院,深圳市药品检验研究院,深圳市药品检验研究院
  • 收稿日期:2018-11-08 修回日期:2018-11-08 出版日期:2018-12-25 发布日期:2018-12-25

Determination of Related substances in Benazepril Hydrochloride Tablets by LC-MS

liang ai xian,,, and   

  1. Shenzhen Institute for Drug Control,Shenzhen Institute for Drug Control,Shenzhen Institute for Drug Control,Shenzhen Institute for Drug Control,
  • Received:2018-11-08 Revised:2018-11-08 Online:2018-12-25 Published:2018-12-25

摘要: 目的:建立盐酸贝那普利片中有关物质的液相色谱-质谱联用(LC-MS)分析方法。方法:以梯度洗脱方式对盐酸贝那普利片的有关物质进行分离,流动相为0.1 mol·L-1醋酸铵溶液(冰醋酸调节pH为3.0)-甲醇,采用Waters SunFire C18柱(2.1 mm×150 mm,5 μm),检测波长为240 nm,进样量20 μL,柱温35 ℃,流速0.2 mL·min-1;质谱扫描范围为100~1 000 amu。结果:在上述条件下,测定了不同厂家的盐酸贝那普利片中有关物质的含量,采用LC-MS法分析了特定杂质的化学结构信息。结论:本分析方法适用于国产盐酸贝那普利片有关物质的组成分析和结构研究。

Abstract: Objective:To develop a liquid chromatograph-mass spectrometer(LC-MS) method for the determination of related substances in Benazepril hydrochloride tablets. Methods:The separation was performed on a Waters SunFire C18 column(2.1 mm×150 mm,5 μm) at a flow rate of 0.2 mL·min-1 and an injection volume of 20 μL, by a gradient elution using 0.1 mol·L-1 ammonium acetate solution(acetic acid adjusted pH to 3.0) as mobile phase A and methanol as mobile phase B. The detection wavelength was set at 240 nm. The column temperature was 35 ℃. MS scan range was 100-1 000 amu. Results:The proposed method was used to detect the related substances in Benazepril hydrochloride tablets from different pharmaceutical manufactures. The chemical structures of related substances were analyzed by LC-MS.Conclusion:The developed method is appropriate for determination of related substances in Benazepril hydrochloride tablets.