北方药学
北方藥學
북방약학
Journal of North Pharmacy
2015年
11期
8-8,9
,共2页
盐酸艾司洛尔注射液%气相色谱法%甲醇%含量
鹽痠艾司洛爾註射液%氣相色譜法%甲醇%含量
염산애사락이주사액%기상색보법%갑순%함량
Levocarnitine injection%HPLC%Contect%Related compound A
目的：建立气相色谱法测定盐酸艾司洛尔注射液中的甲醇含量。方法：色谱柱：HP-INNOWaX：30m×0.25μm×250μm；载气：氮气；检测器：FID火焰检测器；进样口温度250℃；检测器温度250℃。结果：甲醇在5.02～100.51μg/mL范围内有良好的线性关系，r=0.9998；平均回收率（n=6）为99.70%，RSD=0.51%；有关物质A在8.11～243.36ng范围内呈良好的线性关系，r=1.0000；平均回收率为99.94%（n=6），RSD%=0.31%。结论：本法简单、准确、重复性好，区分力强，可作为盐酸艾司洛尔注射液中甲醇的质控方法。
目的：建立氣相色譜法測定鹽痠艾司洛爾註射液中的甲醇含量。方法：色譜柱：HP-INNOWaX：30m×0.25μm×250μm；載氣：氮氣；檢測器：FID火燄檢測器；進樣口溫度250℃；檢測器溫度250℃。結果：甲醇在5.02～100.51μg/mL範圍內有良好的線性關繫，r=0.9998；平均迴收率（n=6）為99.70%，RSD=0.51%；有關物質A在8.11～243.36ng範圍內呈良好的線性關繫，r=1.0000；平均迴收率為99.94%（n=6），RSD%=0.31%。結論：本法簡單、準確、重複性好，區分力彊，可作為鹽痠艾司洛爾註射液中甲醇的質控方法。
목적：건립기상색보법측정염산애사락이주사액중적갑순함량。방법：색보주：HP-INNOWaX：30m×0.25μm×250μm；재기：담기；검측기：FID화염검측기；진양구온도250℃；검측기온도250℃。결과：갑순재5.02～100.51μg/mL범위내유량호적선성관계，r=0.9998；평균회수솔（n=6）위99.70%，RSD=0.51%；유관물질A재8.11～243.36ng범위내정량호적선성관계，r=1.0000；평균회수솔위99.94%（n=6），RSD%=0.31%。결론：본법간단、준학、중복성호，구분력강，가작위염산애사락이주사액중갑순적질공방법。
Objective To establish a HPLC method for determination of the content and related compound A in Levocarnitine injection. Methods A column of silicagel column was adopted;and the mobile phase was the mixture of acetonitrile-phosphate buffer(0.05mol/Lsodium hydrogen phosphate,with phosphoric acid to adjust PH 5.5)=60∶40;The detection wavelength was set at 205nm;the flow rate was 1.0mL/min.Results Levocarnitine showed a good linear relationship in the range of 28.16μg~52.30μg (r=0.9999);The average recovery (n=6)was 99.70%(RSD=0.51%);The related compound A of Levocarnitine showed a good linear relationship in the range of 8.112ng~243.36ng(r=1.0000);The average recovery(n=6) was 100.07%(RSD=0.36%). Conclusion The method is simple,accurate and reproducible,which can be uses for the quality control of Levocarnitine injection.
