CAJ | 학술논문

目的：建立高效液相色谱（ HPLC）法，检测甲磺酸伊马替尼脂质体的含量及有关物质。方法 Kromasil C18柱，流动相 A 为辛烷磺酸钠溶液-甲醇（42：58）；流动相 B 为辛烷磺酸钠溶液-甲醇（4：96）；梯度洗脱，流速为1.2 mL·min-1，柱温室温，检测波长268 nm。结果在选定的色谱条件下，甲磺酸伊马替尼专属性良好，在线性范围1~100μg·mL-1内线性关系良好，r=0.9991（n=5）。结论该方法用于检测甲磺酸伊马替尼脂质体的含量及有关物质准确、灵敏、可靠。
목적：건립고효액상색보（ HPLC）법，검측갑광산이마체니지질체적함량급유관물질。방법 Kromasil C18주，류동상 A 위신완광산납용액-갑순（42：58）；류동상 B 위신완광산납용액-갑순（4：96）；제도세탈，류속위1.2 mL·min-1，주온실온，검측파장268 nm。결과재선정적색보조건하，갑광산이마체니전속성량호，재선성범위1~100μg·mL-1내선성관계량호，r=0.9991（n=5）。결론해방법용우검측갑광산이마체니지질체적함량급유관물질준학、령민、가고。
Objective To establish a method for determination of imatinib mesylate liposome and related substances. Methods The liquid chromatography was carried out on a Kromasil C18 column. The mobile phase A consisted of methanol-octane sulfonate solution(42:58). The mobile phase B consisted of methanol-octane sulfonate solution(4:96). The flow rate of gradient elution was 1. 2 mL·min-1 . The detection wavelength was 268 nm. The column temperature was room temperature. Results The intermediates and degraded substances could be seperated under the selected chromatographic conditions. Imatinib mesylate showed a good linear relationship within 1-100μg·mL-1,r=0. 999 1(n=5). Conclusion The method is specific, accurate,sensitive,and simple,and can be used for quality control of imatinib mesylate liposome.