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目的:建立重组人心钠肽中残留溶剂乙腈的气相色谱分离测定方法。方法:采用DB-624弹性石英毛细管色谱柱(30m×0.32mm,1.8μm),载气为氮气,氢火焰离子化检测器FID,进样口温度为250℃;检测器温度为250℃;柱温为40℃保持8min。分流比10∶1,水为溶剂,乙醇为内标物。结果:使用该方法被测物乙腈能得到良好的分离与测定,峰面积与浓度呈良好的线性关系,精密度良好。结论:方法准确可靠,可用于重组人心钠肽药品中有机溶剂残留量的检测。
Objective: To establish a method for the determination of residual solvent acetonitrile in recombinant human atrial natriuretic peptide by gas chromatography. Methods: DB-624 elastic silica capillary column (30m × 0.32mm, 1.8μm) was used. The carrier gas was nitrogen and hydrogen flame ionization detector FID. The inlet temperature was 250 ℃. The detector temperature was 250 ℃. The temperature was 40 ℃ for 8min. Split ratio of 10: 1, water as solvent, ethanol as internal standard. Results: Using this method, the analyte acetonitrile could be well separated and measured. The peak area and concentration showed a good linear relationship and the precision was good. Conclusion: The method is accurate and reliable and can be used for the determination of residual organic solvents in recombinant human atrial natriuretic peptide.