利拉萘酯及其软膏含量的HPLC测定  

Quantification of liranaftate in the ointment by HPLC

作　　者：宋敏[1] 杭太俊[1] 吴晓鸾[1] 

机构地区：[1]中国药科大学药物分析室,南京210009

出　　处：《中国新药杂志》2005年第9期1165-1167,共3页Chinese Journal of New Drugs

摘　　要：目的:建立高效液相色谱法测定利拉萘酯及其软膏的含量.方法:采用Shimpack C18(150 mm×6.0mm,5 μm)色谱柱,以pH 3.5磷酸盐缓冲溶液(磷酸二氢铵2 g-三乙胺2 mL-磷酸1 mL-水1 000 mL)-甲醇(10:90)为流动相,流速1.0 mL·min-1,在254 nm波长处同时检测利拉萘酯和米氮平(内标物质).结果:利拉萘酯浓度在1.0～150μg·mL-1范围内,色谱响应线性良好(r＞0.999 9),软膏中利拉萘酯含量测定的平均回收率为100.1%,精密度良好(RSD=0.42%).结论:HPLC内标法测定软膏中利拉萘酯的含量结果准确、可靠,重现性好.Objective：To establish a HPLC method for the quantization of liranaftate in its ointment. Methods： The liranaftate was assayed by an optimal HPLC, which was run over a Shimpack C18（150 mm×6.0 mm, 5μm） column, an eluate consisted of pH 3.5 phosphate buffer （monoammonium phosphate 2g-TEA 2mL-phosphoric acid 1mL-water 1 000 mL）-methanol （10：90） mixture with a flow rate of 1.0 mL·min^-1 and a UV detection at 254 nm. Mirtazapine was used as an internal standard. Results：The calibrated linear curve of liranaftate concentration was found in the range of 1.0-150μg·mL^-1（ r〉0. 999 9）. The average recovery rate was （100.1±0.42）%. Conclusion： This HPLC method was accurate, reliable and reproducible for the quantization of liranaftate in its ointment.

关 键 词：利拉萘酯 软膏 含量测定 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学] R978.5