HPLC测定氯沙坦钾的含量及有关物质

Assay and test for related substances of Losartan potassium by HPLC

目的建立测定氯沙坦钾的含量及有关物质的方法.方法采用HPLC法,在Kromasil C18 (250 mm×4.6 mm,5 μm) 柱上,以乙腈- 0.1%磷酸溶液(50∶50) 为流动相, 于230 nm检测, 流速1.0 ml·min-1.结果氯沙坦钾在100～500 μg·ml-1范围内线性关系良好, 回归方程:A=32.54C+42.87(r=0.9999).精密度试验的RSD=0.3%(n=6),检测限为0.25 ng.结论所建方法简便、快速、结果准确.

OBJECTIVE To establise an HPLC method for determination of Losartan potassium and its related substances. METHODS The chromatographic conditions were as follow： Kromasil C18 column （250mm × 4.6 mm, 5 μm）, acetonitrile- 0.1% phosphoric acid （50： 50） as mobile phase, flow rate was 1.0 ml. min^-1, wavelength of detector was set at 230 nm. RESULTS The standard curve was hnear in the range of 100 - 500 μg. ml^-1 and the correlation coefficient was 0.9999. The precision of Losartan potassium was good with RSD of 0.30% （ n = 6）. CONCLUSION The method is simple, rapid, accurate and reliable.