高效液相色谱法测定氟康唑滴眼液的含量

目的建立一种采用高效液相色谱法测定氟康唑滴眼液含量的方法。方法色谱柱为Diamonsil Cl8不锈钢柱(250.0mm×4.6mm,5μm),流动相为磷酸盐缓冲液pH7.0-甲醇(55∶45),检测波长261nm,柱温20℃,流速1.0mL/min。结果样品中主药与其他物质分离良好;氟康唑检测浓度0.0992～0.992mg/mL范围内,与峰面积积分值线性关系良好(r=0.9999);平均回收率为99.87%(RSD=0.22%)。结论采用HPLC法操作方便、结果准确、专属性强、重现性好,适合氟康唑滴眼液的含量测定。

Determination of the content of fluconazole eye drops by HPLC

Objective To establish a HPLC method for the determination of content in fluconazole eye drops.Methods The determination was performed on Diamonsil Cl8 column(250.0 mm×4.6 mm,5μm).The mobile phase consisted phosphate buffer solution-methanol(55:45)with a flow rate 1.0 mL/min,the detection wavelength was set at 261nm,and column temperature was set at 20 ℃. Results Fluconazole and the related substances in samples were well separated.The detectable concentration of fluconazole was from 0.099 2 mg/mL to 0.992 mg/mL(r=0.999 9).The average recovery was 99.87%(RSD=0.22%). Conclusion The method of HPLC is simple,rapid and accurate.It is suitable for the determination of the content in fluconazole eye drops.