HPLC法测定氯雷他定片含量

Content determination of Loratadine Tablets by HPLC

目的:建立测定氯雷他定片中氯雷他定含量的高效液相色谱法。方法:采用色谱柱为Diamonsil C18(200 mm×4.6 mm,5μm);流动相为乙腈-磷酸盐缓冲液(用磷酸调节pH值至3.0)(70∶30),流速为1.0 ml/min,检测波长为247 nm,柱温为25℃。结果:回归方程为Y=760 965X-82 937,r=0.999 2(n=6)。表明进样量在0.80～4.80μg范围内有良好的线性关系,平均回收率为99.60%,RSD为0.39%(n=9)。结论:本法测定氯雷他定片的含量简单、灵敏、重现性好,能够准确地控制药品质量。

Objective： To establish the content determination of Loratadine Tablets by HPLC method.Methods： The column was Diamonsil C18（200 mm × 4.6 mm,5 μm）;mobile phase was acetonitrile-phosphate buffer（pH value adjusted to 3.0 with phosphoric acid）（70∶30）;flow rate was 1.0 ml/min;detection wavelength was 247 nm;column temperature was 25℃.Results： The regression equation was Y=760 965X-82 937,r=0.999 2（n=6）,which showed that the sample had good linear relationship in the range of 0.80-4.80 μg;the average recovery was 99.60% with RSD of 0.39%（n=9）.Conclusion： This method is simple,sensitive and reproducible for the content determination of Loratadine Tablets.It can accurately control the drug quality.