高效液相色谱法测定人乳汁中拉莫三嗪的浓度  

Determination of lamotrigine in breast milk in epilepsy women by RP-HPLC

作　　者：张媞[1] 李新林[1] 周敬凯 李爽[1] 肇丽梅[1] 

机构地区：[1]中国医科大学附属盛京医院药学部,沈阳110004

出　　处：《中国临床药理学杂志》2015年第5期375-377,387,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家自然基金资助项目(81302857);辽宁省自然科学基金资助项目(2013021079)

摘　　要：目的建立测定乳汁中拉莫三嗪浓度的高效液相色谱方法。方法以氯唑沙宗为内标,乳汁样品用乙醚萃取,用C18柱分析。流动相为乙腈-0.05mol·L-1磷酸二氢钠水溶液（26.5∶73.5,p H 4.5）,流速为1.0 m L·min-1;检测波长为220 nm,柱温为25℃。结果拉莫三嗪在0.02~10.00μg·m L-1内线性关系良好（r=0.999 5）,定量下限为0.02μg·m L-1。高、中、低质控样品提取回收率分别为71.45%,70.26%,72.63%,日内、日间RSD均〈15%。1例癫痫产妇拉莫三嗪的乳药浓度为（0.96±0.11）μg·m L-1,乳药/血药浓度比为（0.64±0.04）。结论该方法操作简便、准确、灵敏度高,可用于拉莫三嗪的乳药浓度检测。Objective To develop an HPLC method for the determina- tion of lamotrigine in breast milk of epilepsy women. Methods With chlorzoxazone as internal standard, the breast milk was extracted with diethyl ether. The analysis was conducted on a Clseolumn. The flow rate was 1.0 mL · min-1 and the column temperature was 25 ℃. The detec- ting wavelength was set at 220 nm. The mobile phase consisted of aceto- nitrile - 0. 05 tool ·L-1 biphosphate sodium （26. 5： 73.5, pH 4. 5）. Results The linear range of lamotrigine was 0. 02 - 10. 00 μg · mL-1 （r = 0. 999 5 ） . The range of extraction recovery ratio of high, middle and low quality control samples were 71.45% ,70. 26% ,72. 63%. The intra -and inter- day precision was both less than 15%. The concentra- tion of the breast milk in the epilepsy woman was （0. 96 ± 0. 11 ） μg·mL-1,and the milk - to - plasma ratio was（0.64 ± 0.04）. Conclusion The method is simple, accurate and sensitive, which is suitable for the study of therapeutic drug concentration monitoring of lam- otrigine in the breast milk.

关 键 词：拉莫三嗪 高效液相色谱法 乳药浓度 

分 类 号：R969.1[医药卫生—药理学] R971.6[医药卫生—药学]