HPLC法测定盐酸坦洛新的含量及有关物质

目的：建立以高效液相色谱法测定盐酸坦洛新及其有关物质含量的方法。方法：色谱柱为Kromasil C18（250mm×4．6mm，5μm），流动相为乙腈-0．2mol·L^-1磷酸二氢钾溶液-0．2mol·L^-1磷酸溶液=5：7：7（v／v），检测波长为225nm，流速为1ml·min^-1，柱温为30℃，进样量为20μl。结果：盐酸坦洛新检测浓度的线性范围为50．12—350．84μg·ml^-1（r=0．9999）；平均回收率为99．92％（RSD=0．6％）。结论：本方法简便、准确、专属性强，可用于该原料的质量控制。

Determination of Tamsulosin Hydrochloride and its Related Substances by HPLC

Objective： To establish a method for the determination of tamsulosin hydrochloride and its related substances. Method： HPLC was performed on Kromasil C18（250 mm × 4. 6 mm, 5 μm） column with acetonitrile-0. 2 mol. L^-1 potassium dihydrogen phosphate-0. 2 mol-L^-1 phosphoric acid （5： 7：7 ,v/v） as the mobile phase,flow rate was lml.min^-1. The detection wavelength was at 225 nm. The column temperature was 30℃ and the sample size was 20 μl. Result： The linear range of tamsulosin hydrochloride was 50. 12-350. 84 μg·ml^-1 （r =0. 999 9） ,the average recovery was 99. 92% （RSD =0. 6% ）. Conclusion： The method is simple,accurate, special and can be used for the quality control of tamsulosin hydrochloride.