北方药学
北方藥學
북방약학
JOURNAL OF NORTH PHARMACY
2015年
1期
2-3,4
,共3页
左卡尼汀注射液%高效液相色谱%含量%有关物质A
左卡尼汀註射液%高效液相色譜%含量%有關物質A
좌잡니정주사액%고효액상색보%함량%유관물질A
Levocarnitine injection%HPLC%Contect%Related compound A
目的：建立HPLC法测定左卡尼汀注射液中的含量及有关物质A。方法：色谱柱：硅胶为填充剂（250mm×4.6mm，5um）；乙腈∶磷酸盐缓冲液（0.05mol/L磷酸氢二钠，用稀磷酸调pH值为5.50）=60∶40为流动相；检测波长为205nm；流速为1.0ml/min。结果：左卡尼汀在28.16～52.30μg范围内呈良好的线性关系，r=0.9999；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（n=6）为100.07%，RSD=0.36%。结论：本法简单、准确、重复性好、区分力强，可作为左卡尼汀注射液的质控方法。
目的：建立HPLC法測定左卡尼汀註射液中的含量及有關物質A。方法：色譜柱：硅膠為填充劑（250mm×4.6mm，5um）；乙腈∶燐痠鹽緩遲液（0.05mol/L燐痠氫二鈉，用稀燐痠調pH值為5.50）=60∶40為流動相；檢測波長為205nm；流速為1.0ml/min。結果：左卡尼汀在28.16～52.30μg範圍內呈良好的線性關繫，r=0.9999；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（n=6）為100.07%，RSD=0.36%。結論：本法簡單、準確、重複性好、區分力彊，可作為左卡尼汀註射液的質控方法。
목적：건립HPLC법측정좌잡니정주사액중적함량급유관물질A。방법：색보주：규효위전충제（250mm×4.6mm，5um）；을정∶린산염완충액（0.05mol/L린산경이납，용희린산조pH치위5.50）=60∶40위류동상；검측파장위205nm；류속위1.0ml/min。결과：좌잡니정재28.16～52.30μg범위내정량호적선성관계，r=0.9999；평균회수솔（n=6）위99.70%，RSD=0.51%；유관물질A재8.11～243.36ng범위내정량호적선성관계，r=1.0000；평균회수솔（n=6）위100.07%，RSD=0.36%。결론：본법간단、준학、중복성호、구분력강，가작위좌잡니정주사액적질공방법。
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 28.16~52.30μg (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 8.112~243.36 ng (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.
