CAJ | 학술논문

目的:建立经过验证的人血浆中拉莫三嗪( LTG)浓度测定的液质联用( HPLC-MS/MS)方法,并应用于临床样本LTG的血药浓度测定. 方法::色谱柱使用Kromasil C8 (50 mm × 2. 1 mm,5μm)柱,用含0. 1%甲酸的水和甲醇进行梯度洗脱,流速0. 6 ml· min-1 ,柱温40℃. LTG和内标噻氯匹定( IS)在ESI正离子模式下的监测离子对分别为:m/z 256. 0>211. 0和m/z 264. 1>154. 0. 结果:LTG浓度在0. 02~2 μg· ml-1范围内线性很好,日内和日间的准确度RE和精密度RSD均小于15%.LTG在低、中和高浓度的回收率在91. 94% ~100. 28%之间,样品在所有考察的条件下均稳定并且10倍稀释不影响测定结果.结论:本研究建立的使用HPLC-ms/ms测定LTG血浆浓度的方法准确、稳定,简便,并可应用于LTG的临床血药浓度监测.
목적:건립경과험증적인혈장중랍막삼진( LTG)농도측정적액질련용( HPLC-MS/MS)방법,병응용우림상양본LTG적혈약농도측정. 방법::색보주사용Kromasil C8 (50 mm × 2. 1 mm,5μm)주,용함0. 1%갑산적수화갑순진행제도세탈,류속0. 6 ml· min-1 ,주온40℃. LTG화내표새록필정( IS)재ESI정리자모식하적감측리자대분별위:m/z 256. 0>211. 0화m/z 264. 1>154. 0. 결과:LTG농도재0. 02~2 μg· ml-1범위내선성흔호,일내화일간적준학도RE화정밀도RSD균소우15%.LTG재저、중화고농도적회수솔재91. 94% ~100. 28%지간,양품재소유고찰적조건하균은정병차10배희석불영향측정결과.결론:본연구건립적사용HPLC-ms/ms측정LTG혈장농도적방법준학、은정,간편,병가응용우LTG적림상혈약농도감측.
Objective:To establish an HPLC-MS/MS method for the determination of lamotrigine ( LTG) in human plasma to be applied in the clinical therapeutic drug monitoring. Methods:LTG was analyzed on a Kromasil C8 (50 mm × 2. 1 mm,5μm) column. Methanol and water (both containing 0. 1% formic acid) was used as the mobile phase with gradient elution. The flow rate was 0. 6 ml ·min-1 at the column temperature of 40℃. The ion transitions under an ESI positive model were performed at m/z 256. 0>211. 0 and m/z 264. 1>154. 0 for LTG and ticlopidine (internal standard, IS), respectively. Results: The calibration curve of LTG was linear within the range of 0. 02-2 μg · ml-1 . The recoveries of LTG at three quality control levels were within the range of 91. 94%-100. 28%. LTG was stable under all tested conditions and the dilution (the dilution factor was 10) had no influence on the accuracy and precision of LTG determination. Conclusion:The HPLC-MS/MS method for the determination of LTG developed in the study is accuracy, stable and convenient, and is applicable in the clinical therapeutic drug monitoring of LTG.