气相色谱法测定非诺贝酸中的残留溶剂

Determination of residual solvents in fenofibric acid by gas chromatography

目的：本实验采用顶空进样技术、气相色谱分离以及FID检测器联用直接测定非诺贝酸药物中5种残留溶剂。方法：实验过程中研究了升温程序、溶剂、分流比、流量等条件对5种物质分离的影响。结果：所建立的方法在各种残留溶剂的浓度范围内具有良好的线性关系，r≥0.9999，精密度测定RSD≤4.0％，耐用性较好，对于供试品中5种溶剂的平均回收率在90.0％~110.0％范围内。结论：该技术具有检测固体药品中残留溶剂的能力。

Objective：Five kinds of residual solvent in fenofibric acid were detected through headspace sampling technolo-gy,gas chromatographic separation and FID detection. Methods：The effects of temperature program,solvents,split ratio and flow rate on separation of five kinds of solvent were studied. Results：The established method had good linear relation-ship in concentration range of five kinds of solvent （r≥0.999 9）. RSD of precision was less than 4.0%and average recov-ery rate of five kinds of residual solvent was from 90.0%to 110.0%. Conclusion：The technology could be used to detect residual solvent in solid drug.