【作者】 李靖； 季金苟；

【Author】 LI Jing~(1,2) and JI Jin-gou~(*1)(1.College of Chemistry and Chemical Engineering,Chongqing University,Chongqing 400030;2.Chongqing Taihao Pharmaceutical Co.Ltd.Chongqing 400039)

【机构】 重庆大学化学化工学院； 重庆泰濠制药有限公司；

【摘要】 为建立度骨化醇原料药含量的测定方法,采用HPLC法,色谱柱:YMC-Pack ODS-AQ(150×4.6 mmS-3μm),乙腈-水为流动相,流速:1.7mL/min,柱温:35℃,检测波长:205 nm。结果显示:度骨化醇在4000～1.8μg/mL内呈良好线性关系关系(r=0.99974),RSD=0.19%(n=6),平均回收率为99.9%(RSD=0.22%,n=9),中间精密度RSD=0.19%。方法适用于度骨化醇原料药的质量控制。更多还原

【Abstract】 A HPLC method to determine the content of doxercalciferol was established.The analysis was carried out with a YMC-Pack ODS-AQ column(150×4.6 mm S-3μm) and a mobile phase consisted of acetonitrile and water. The flow rate was 1.7 mL/min and column temperature was 35℃.The UV detection was set at 205 nm.The results showed that the calibration curve was linear(r=0.99974) within the range of 4000～1.8μg/mL for Doxercalciferol. The RSD of repeatability test and intermediate precision test were both 0.19%.The average recovery rate was 99.9% for three different levels of doxercalciferol.Therefore this method is simple,rapid,accurate and effective for the determination of doxercalciferol and for the quality control of doxercalcfferol.更多还原