CAJ | 학술논문

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。
목적：본실험채용정공진양기술、기상색보분리이급FID검측기련용직접측정비낙패산약물중5충잔류용제。방법：실험과정중연구료승온정서、용제、분류비、류량등조건대5충물질분리적영향。결과：소건립적방법재각충잔류용제적농도범위내구유량호적선성관계，r≥0.9999，정밀도측정RSD≤4.0％，내용성교호，대우공시품중5충용제적평균회수솔재90.0％~110.0％범위내。결론：해기술구유검측고체약품중잔류용제적능력。
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.