摘要
目的建立人血浆中洛匹那韦的高效液相色谱测定方法,用于临床进行药物浓度监测。方法血浆样品经醋酸乙酯液液萃取后,采用高效液相色谱法(HPLC)进行分析。Eclipse C18柱分离,流动相采用甲醇-0.1 mol·L-1醋酸铵溶液,流速为1mL.min-1;梯度洗脱在0～6 min甲醇-0.1 mol·L-1醋酸铵溶液为70∶30,6.1～15 min甲醇-0.1 mol·L-1醋酸铵溶液为80∶20;利用光电二极管阵列检测器对流份进行双波长同时检测(洛匹那韦210 nm,内标298 nm),柱温30℃。结果内源性物质不干扰测定,洛匹那韦的线性范围为1～12 mg.L-1(r=0.997 0),最低定量限为1 mg.L-1,基质效应为92.11%～105.31%(n=5),萃取回收率为73.32%～89.50%(n=5),批内和批间精密度(RSD%)分别为1.75～5.99(n=5)和4.97～9.79(n=3)。结论建立的HPLC方法简便、灵敏、准确、所需样本量小,可以用于临床血药浓度测定。
OBJECTIVE To develop a high performance liquid chromatography （HPLC） method for the determination of lopinavir in human plasma. METHODS The plasma samples were extracted with ethyl acetate, and separated on an Eclipse C18 column, using methanol-0. 1mL·min^-1 ammonium acetate as the mobile phase. The flow rate was 1.0 mL·min^-1. The gradient elution was 70：30 at 0 min to 6 min, changed to 80：20 at 6. 1 min to 15 rain. The fractions were simultaneously detected by DAD with wavelength at 210 nm for lopinavir and for 298 nm internal standard. RESULTS The method was linear for lopinavir in the range of 1 - 12 mg·L^-1. The correlaton coefficient was 0. 997 0 and the LLOQ was 1.0 mg·L^-1. The matrix effect was from 92. 11% to 105.31% . The extraction recovery was in the range of 73.32% - 89. 50% （n = 5 ）. The intra-day and inter-day precisions （ RSD% ） were 1.75 - 5.99 （n = 5） and 4. 97 - 9. 79 （n = 3）, respectively. CONCLUSION The HPLC method is simple, sensitive and accurate. It is suitable for the determination of lopinavir in human plasma.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2011年第6期463-466,共4页
Chinese Pharmaceutical Journal
基金
十一五国家科技重大专项(2008ZX10001-008)
中南大学博士后基金资助(20100471000)
作者简介
姚亚敏，女，研究实习员研究方向：药物分析 Tel：（021）37990333-5302 E—mail：yym-210@163．com
