RP-HPLC测定阿那曲唑含量及有关物质的方法学研究

 目的测定阿那曲唑片的含量及有关物质检查。方法采用反相高效液相色谱法，ODS色谱柱(4.6 mm×200 mm，填料：Hypersil，粒度：5 μm)，以水-乙腈-甲醇-三氟乙酸(560∶180∶260∶0.5)为流动相，流速1.0 mL·min^-1，检测波长215 nm，柱温40℃，测定。结果RP-HPLC测定的线性范围为5.11～35.77μg·mL^-1，相关系数r=0.999 9；片剂中阿那曲唑的平均回收率为99.97%，RSD=0.94%，n=9；最低检测限1.07 ng；精密度(RSD=0.3%)良好。结论该法操作简便、快速、准确，适用于阿那曲唑片的含量测定及其有关物质检查。

Research on determination of content and the related substances of anastrozole in tablets by RP-HPLC

OBJECTIVE To determine the content and the related substances of anastrozole in tablets.METHOD A RP HPLC method was used.The mobile phase was consisted of water acetonitrile methol TFA (560∶180∶260∶0.5),at a flow rate of 1.0 mL·min^-1 with the column temperature 40℃.The detection wavelength was 215 nm.RESULTS The linear calibration curves were obtained over the range of 5.11～35.77μg·mL^-1 (r=0.999 9). The average recoveries of anastrozole was 99.97% (RSD=0.94%) in tablets.The detection limit was 1.07 ng.The precision of the method (RSD=0.3%) was good.CONCLUSION The method was proved to be suitable for detecting the content and the related substances of anastrozole in tablets,which offers the advantages of specifity,speed,and sensitivity.