CAJ | 학술논문

目的：建立盐酸头孢卡品酯中7种有机溶剂残留量的检测方法，并进行了方法学研究。方法以N，N二甲基甲酰胺为溶剂，采用DB-1701毛细管柱（30 m ×0.53 mm，1.0μm），载气为氮气，FID为检测器，采用程序升温，初始柱温40℃，保持10 min，再以15℃·min-1的速率升至180℃，保持5 min。结果7种残留溶剂均能得到有效的分离，在所考察的溶液浓度范围内线性关系良好，r为0.9989~0.9998，平均回收率为97.9%~103.3%。结论该方法简便、灵敏度高、结果准确、重复性好，可用于原料药中有机残留溶剂的检测。
목적：건립염산두포잡품지중7충유궤용제잔류량적검측방법，병진행료방법학연구。방법이N，N이갑기갑선알위용제，채용DB-1701모세관주（30 m ×0.53 mm，1.0μm），재기위담기，FID위검측기，채용정서승온，초시주온40℃，보지10 min，재이15℃·min-1적속솔승지180℃，보지5 min。결과7충잔류용제균능득도유효적분리，재소고찰적용액농도범위내선성관계량호，r위0.9989~0.9998，평균회수솔위97.9%~103.3%。결론해방법간편、령민도고、결과준학、중복성호，가용우원료약중유궤잔류용제적검측。
Objective To eastablish a method for the determination of seven residual solvents in cefcapene pivoxil hydrochloride and to investigate the technology. Methods Using N,N-dimethylformamide as solvent,achieved by the col-umn of DB-1701(30 m × 0. 53 mm,1. 0μm),N2 as carrier gas,FID detector and programably tempreture. The initial tem-preture was kept at 40 ℃ for 10 min,and the tempreture was raised to 180 ℃ at rate of 15 ℃·min-1 and lasted 5 min. Results Seven residual solvents was completely separated and there were good linearies(r=0. 998 9~0. 999 8). The av-erage recovery was in the range of 97. 9% ~103. 3%. Conclusion The method was simple,sensitive,accurate and repro-ducible,it can be used for the analysis of the organic solvents in bulk pharmaceuticals.