目的:建立反相高效液相色谱测定来氟米特的方法。方法:采用Hypersil ODS C₁₈柱,流动相为甲醇-水-磷酸,检测波长为260nm,流速为1.0ml·min^-1,进样量为20μl,以萘或联苯酚为内标。结果:两峰分离完全,以萘为内标:来氟米特线性范围0.0955～7.6400μg·ml^-1(r=0.9999),检测限为0.8ng,日内偏差和日间偏差分别为0.76%(n=5)和0.86%(n=5),平均回收率为99.66%(RSD=0.80%);以联苯酚为内标:来氟米特线性范围0.141～8.460μg·ml^-1(r=0.9997),检测限为0.8ng,日内偏差和日间偏差分别为0.86%(n=5)和1.06%(n=5),平均回收率为100.48%(RSD=1.60%)。结论:方法简便,结果准确。

OBJECTIVE:To establish a method for determination of leflunomide using reversed-phase high performance liquid chromatography.METHODS:Chromatographic conditions included Hypersil ODS C₁₈column and the mobile phase consisting of a mixture of methanol-water-phosphoric acid.Detection wavelength was at 260 nm.The flow rate was 1.0 ml·min^-1.Naphthalene or p-phenylphenol was selected as the internal standard.RESULTS:When naphthalene was used as the internal standard,the linearity between concentration and peak area ratio was obtained from 0.0955μg·ml^-1to 7.6400μg·ml^-1(r=0.9999),the detection limit was 0.8ng,within-day and between-day variation coefficients were 0.76% (n=5) and 0.86%(n=5),the average recovery was 99.66% (RSD=0.80%).When p-phenylphenol was used as the internal standard,the linearity between concentration and peak area ratio was obtained from 0.141μg·ml^-1 to 8.460μg·ml^-1(r=0.9997),the detection limit was 0.8ng,within-day and between-day variation coefficients were 0.86% (n=5) and 1.06%(n=5),the average recovery was 100.48% (RSD=1.60%).CONCLUSION:The method was found to be simple and accurate.