氯雷他定糖浆含量及有关物质的HPLC测定

Determination of Loratadine Syrup and Its Related Substance by HPLC

目的建立高效液相色谱（HPLC）法测定氯雷他定糖浆含量及有关物质。方法采用Beckrman子C18柱（250mm×4．6mm，5μm），以乙腈-甲醇-0．02％二乙胺溶液（50：20：30，磷酸调pH值至4．0±0．1）为流动相，流速1．0ml／min，检测波长247nm。结果氯雷他定在40．0～120．0μg／ml的范围内线性良好，r=0．9999，平均回收率分别为99．5％，相对标准偏差（RSD）=0．4％。结论该方法简单、准确、可靠，重复性好，可用于氯雷他定糖浆剂的含量及有关物质测定。

Objective To establish a method for the determination of loratadine syrup and its related substance by HPLC. Methods A Beckrman C18 column was used, with the mobile phase of acetonitrile-methanol-0.02% diethyamine solution （50： 20： 30, adjust pH to 4.0 ± 0.1 with phosphoric acid）. The flow rate was 1.0 ml/min, and the detection wavelength was 247 nm. Results The calibration curve of loratadine was linear in the range of 40.0 - 120.0 μg/ml, r = 0.999 9. The average recovery was 99.5%, RSD =0.4%. Conclusion The method is simple, rapid, accurate, and has good reproducibility. It can be used to determine the content and its related substance in loratadine syrup.