RP-HPLC法测定氯新地滴眼液中3组分的含量

目的:建立以反相高效液相色谱法测定氯新地滴眼液中氯霉素、地塞米松磷酸钠和去氧肾上腺素含量的方法。方法:色谱柱为Kromasil C18,流动相为甲醇-水(含0.2%三乙胺、0.15%辛烷磺酸钠,用磷酸调pH至3.8)=40∶60,检测波长为230nm,进样量为20μL,流速为1.0mL.min-1,柱温为室温。结果:氯霉素、地塞米松磷酸钠、去氧肾上腺素检测浓度的线性范围分别为125～1 000(r=0.999 3)、25～200(r=0.999 6)、12.5～100(r=0.999 2)mg.L-1;平均回收率分别为99.53%、100.0%、99.24%,RSD分别为0.51%、0.90%、0.72%。结论:本方法简单、快速、准确,可用于该制剂的含量测定。

Determination of 3 Kinds of Components in Luxindi Eye Drops by RP - HPLC

OBJECTIVE： To establish a RP-HPLC method for the simultaneous determination of chloramphenical, dexamethsone sodium phosphate and deoxyepinephrine in luxindi eye drops. METHODS： The determination was performed on Kromasil C18 column and the mobile phase consisted of methanol water （containing 0.2% triethylamine and 0.15% octane sulfonic acid sodium, pH was adjusted to 3.8 with phosphoric acid, 40 ： 60） with flow rate at 1.0 mL· min^-1. The detective wavelength was set at 230 nm; the sample size was 20μL and the column temperature was set at room temperature. RESULTS： The linear ranges of chlormphenical, dexamethasone sodium phosphate and deoxyepinephrine were 125～1 000 （r = 0.999 3）, 25-200 （r = 0.999 6） and 12.5～100 （r = 0.999 2） mg·L^-1, respectively, with the average recoveries rate at 99.53%, 100.0% and 99.24% , and RSD at 0.51%, 0.90% and 0.72% , respectively. CONCLUSIONS： This method is simple, rapid and accurate, and it is applicable for the content determination of this preparation.