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机构地区:[1]重庆市药品检验所,重庆401121
出 处:《中国药业》2010年第13期36-37,共2页China Pharmaceuticals
摘 要:目的建立测定托吡卡胺滴眼液含量的高效液相色谱法。方法采用LunaC8色谱柱(250mm×4.6mm,5μm),流动相为0.01mol/L辛基磺酸钠溶液(用磷酸调pH至3.0)-甲醇(45:55),检测波长为254nm,柱温33℃,流速1mL/min。结果托吡卡胺质量浓度在25.26~353.64μg/mL范围内与峰面积线性关系良好,r=0.9999,平均回收率为100.30%,RSD为0.30%(n=9)。结论高效液相色谱法与国家标准中的含量测定方法相比,简单、快速,回收率和重复性良好,其线性、重复性、回收率均符合规定,可作为托吡卡胺滴眼液的含量测定方法。Objective To establish a method for the content determination of Tropicamide Eye Drops. Methods To use the Luna Cs column (250 mm×4. 6 mm, 5μm) and the mixture of 0.01 mol/L sodium 1-octanesulfonate solution-methanol (45:55) as the mobile phase. The flow rate was 1 mL/min and the detection wavelength was 254 nm and the temperature of column was 33 ℃. Results The linear relation of the peak area and tropicamide concentration was in the range of 25.26 - 353.64 μg/mL, r = 0. 999 9. The average recovery rate was 100.30%, RSD=0.30% (n=9). Conclusion HPLC method is simple, accurate and sensitive, which can be used for controlling the quality of Tropicamide Eye Drops.
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