【摘要】 目的:建立来曲唑口腔崩解片中来曲唑的含量及均匀度的测定方法。方法:以ZORBAXSB-C18(4.6mm×150mm,5μm)为色谱柱,水-乙腈(60∶40)为流动相,流速1.0mL.min-1,检测波长240nm,室温。结果:来曲唑在0.25～16mg.L-1范围内线性关系良好(r=0.9997),平均回收率为100.4%,RSD为0.27%。结论:本法简便,快速,准确,可用于该制剂的质量控制。更多还原

【Abstract】 OBJECTIVE To establish an HPLC method for determination of content and uniformity of letrozole in letrozole orally disintegrating tablets.METHODS The ZORBAX SB-C18 column(4.6 mm×150 mm,5 μm)was used as analytical column with water-acetonitrile(60∶40)as mobile phase.The flow rate was 1.0 mL·min-1.The column temperature was ambient temperature.The detection wavelength was 240 nm.RESULTS The calibration curve of letrozole was linear in the range of 0.25-16 mg·L-1(r=0.999 7),and the average recovery was 100.4%,RSD=0.27%.CONCLUSION The method is simple,rapid,accurate,and can be used as determination and quality control for letrozole orally disintegrating tables.更多还原