【摘要】 目的 :建立格拉司琼片中主药格拉司琼的含量测定方法。方法 :采用反相高效液相色谱法 ,在SpherisorbC18色谱柱上 ,以乙腈 - 0 .0 2mol·L-1磷酸二氢钾缓冲液 (含 3 %三乙胺 ,pH 2 .2 ) =2 5∶75作流动相 ,流速 1ml·min-1,检测波长 3 0 1nm ,进样量 2 0 μl考察了流动相 pH、流动相中三乙胺用量等因素对色谱分离的影响。 结果 :格拉司琼与片剂辅料和有关杂质可完全分离 ,格拉司琼线性范围 10 .5～ 63 .0 μg·ml-1,平均回收率为 10 0 .0 % ,RSD <1.7%。结论 :该法操作方便 ,专属性强 ,结果准确 ,重现性好。更多还原

【Abstract】 OBJECTIVE:To establish a method for the determination of granistron in tablet . METHODS:HPLC was carried out using a Spherisorb C 18 column(150 mm× 4.6 mm)and a mobile phase consisting of acetonitrile and pH 2.2 , 0.02 mol·L -1 phosphate buffer with 3% triethylamine(25∶75). The ultraviolet detection was at 301 nm, 20 μl portion of the sample solution was chromatographed. The effects of the pH of mobile phase and the amount of triethylamine in the mobile phase on separation were investigated. RESULTS:Grasetron and the other components in samples could be separated completely. The standard curve was linear over the range of 10.5 to 63.0 μg·ml -1 of granistron with r= 0.999 98 . Assay precision was in the range of 0.6 % to 1.7 % and the recovery for granistron was in the range of 99.3 % to 100.7 %. CONCLUSIONS:The proposed method was simple, selective, accurate and precise.更多还原