氯雷他定泡腾片的含量和含量均匀度测定

Determination on content and content uniformity in Loratadine Effervescent Tablets

目的:建立HPLC法测定氯雷他定泡腾片含量和含量均匀度。方法:采用HPLC法,色谱柱:Thermo BDS HY-PERSIL C18(250 mm×4.6 mm,5μm);流动相:甲醇-0.02 mol/L磷酸二氢钾溶液(83∶17);检测波长:247 nm;流速:1.0 ml/min。结果:定量限为0.6 ng,10.0～100.0μg/ml的范围内线性关系良好(r=0.999 9),平均回收率为99.4%(RSD=0.84%,n=9)。结论:经方法学试验,该方法灵敏、可靠、简便,可用于该制剂的含量和含量均匀度的测定。

Objective： To establish the HPLC method for the determination on content and content uniformity in Loratadine Effervescent Tablets. Methods： The column of Thermo BDS HYPERSIL Cls （250min×4.6mm,5μm） was used; mobile phase was CH3OH-0.02 mol/L KH2PO4 （83：17）; flow rate was 1.0 ml/min; detection wavelength was 247 nm. Results： The limit of quantification was estimated to be 0.6 ng. The regression equation showed that the sample had a good linear relationship in the range of 10.0-100.0 μg/ml （r=0.999 9）. The average recovery was 99.4% （RSD=0.84%, n=9）. Conclusion： The method is sensitive, reliable and simple. It is applicable to the determination on the content and content uniformity in Loratadine Effervescent Tablets.