RP-HPLC测定氯雷他定颗粒剂中氯雷他定的含量

Assaying of loratadine in loratadine granules by RP-HPLC

目的测定氯雷他定颗粒剂中氯雷他定及其有关物质的含量.方法采用Shim-Pack CLC C18(5μm,250mm×4.6mm)色谱柱.流动相为甲醇-0.01 mol·L-1磷酸氢二钾缓冲液盐(用磷酸调pH值至7.8)(80:20),流速为1.0ml·min-1,检测波长为247nm.结果氯雷他定在2.0～24μg·ml-1浓度范围内呈线性关系,平均回收率为99.8%,相对标准偏差为0.21%(n=9).结论本实验建立的含量测定方法准确、灵敏、重现性好.

Objective To determine the content of loratadine in loratadine granules by reversed-phase（RP） high performance liquid chromatography （HPLC）. Methods The HPLC system consisted of Shim-Pack CLC C18 column （5μm, 250 mm × 4.6mm ）, methanol ： 0.01 mol· L^-1 monobasic potassium phospnate buffer （ 80： 20） as mobile phase, detection at 247 nm, flow rate 1.0 ml· min^-1. Results The standard curve of loratadine was linear in the concentration range of 2.0-24.0 μg·ml^-1 . The average recovery rate was 99.8% ,and the relative standard deviation was 0.21% （ n = 9）. Conclusion RP-HPLC assay is accurate, sensitive and repeatable.