中国药师
中國藥師
중국약사
CHINA PHARMACIST
2015年
1期
18-19,20
,共3页
刘薇芝%胡汉昆%刘萍%刘巍%张觅%郑保根%刘安妮%颜锵%周利娟%刘一鸣
劉薇芝%鬍漢昆%劉萍%劉巍%張覓%鄭保根%劉安妮%顏鏘%週利娟%劉一鳴
류미지%호한곤%류평%류외%장멱%정보근%류안니%안장%주리연%류일명
气相色谱法%硝酸芬替康唑%有机溶剂残留
氣相色譜法%硝痠芬替康唑%有機溶劑殘留
기상색보법%초산분체강서%유궤용제잔류
GC%Fenticonazole nitrate%Residual organic solvent
目的：：建立测定硝酸芬替原料药中二氯甲烷、甲醇和乙醇3种有机溶剂残留量的分析方法。方法：采用毛细管气相色谱法,色谱柱：OV-1301毛细管色谱柱(30 m ×0.53 mm,3.0μm),检测器：FID；检测器温度：250℃；进样器温度：200℃；载气：氮气；顶空进样。结果：在上述色谱条件下,二氯甲烷、甲醇和乙醇分别在2.436~21.924μg·ml-1(r=0.9988),12.268~110.412μg·ml-1(r=0.9995),20.052~180.468μg·ml-1(r=0.9969)质量浓度范围内线性关系良好。平均回收率分别为99.30%(RSD=2.36%,n=9),100.21%(RSD=1.07%, n=9),100.15%(RSD=1.27%, n=9)。结论：该检测方法灵敏、准确、可靠,可用于硝酸芬替康唑原料药的质量控制。
目的：：建立測定硝痠芬替原料藥中二氯甲烷、甲醇和乙醇3種有機溶劑殘留量的分析方法。方法：採用毛細管氣相色譜法,色譜柱：OV-1301毛細管色譜柱(30 m ×0.53 mm,3.0μm),檢測器：FID；檢測器溫度：250℃；進樣器溫度：200℃；載氣：氮氣；頂空進樣。結果：在上述色譜條件下,二氯甲烷、甲醇和乙醇分彆在2.436~21.924μg·ml-1(r=0.9988),12.268~110.412μg·ml-1(r=0.9995),20.052~180.468μg·ml-1(r=0.9969)質量濃度範圍內線性關繫良好。平均迴收率分彆為99.30%(RSD=2.36%,n=9),100.21%(RSD=1.07%, n=9),100.15%(RSD=1.27%, n=9)。結論：該檢測方法靈敏、準確、可靠,可用于硝痠芬替康唑原料藥的質量控製。
목적：：건립측정초산분체원료약중이록갑완、갑순화을순3충유궤용제잔류량적분석방법。방법：채용모세관기상색보법,색보주：OV-1301모세관색보주(30 m ×0.53 mm,3.0μm),검측기：FID；검측기온도：250℃；진양기온도：200℃；재기：담기；정공진양。결과：재상술색보조건하,이록갑완、갑순화을순분별재2.436~21.924μg·ml-1(r=0.9988),12.268~110.412μg·ml-1(r=0.9995),20.052~180.468μg·ml-1(r=0.9969)질량농도범위내선성관계량호。평균회수솔분별위99.30%(RSD=2.36%,n=9),100.21%(RSD=1.07%, n=9),100.15%(RSD=1.27%, n=9)。결론：해검측방법령민、준학、가고,가용우초산분체강서원료약적질량공제。
Objective:To establish a method for the determination of dichloromethane, methanol and ethanol in fenticonazole ni-trate. Methods:The samples were detected by headspace GC. The column was OV-1301(30 m × 0. 53 mm,3. 0 μm), the detector was FID with nitrogen as the carrier gas, the detector temperature was 250 ℃ and the injector temperature was 200 ℃. Results:The linear range of dichloromethane, methanol and ethanol was 2. 436-21. 924(r=0. 998 8), 12. 268-110. 412(r=0. 999 5) and 20. 052-180. 468 μg·ml-1(r=0. 996 9) with the average recovery of 99. 30% (RSD=2. 36%), 100. 21%(RSD=1. 07%) and 100. 15%(RSD=1. 21%)(n=9), respectively. Conclusion:The detection method is sensitive, accurate and reliable, and can be used in the quality control of fenticonazole nitrate.
