HPLC测定氯雷他定的含量及其有关物质

Determination of Content and Related Substances of Loratadine by HPLC

关键词:  氯雷他定  有关物质  含量测定  高效液相色谱法

Key words:  loratadine  related substances  content determination  HPLC

摘要:

目的 建立高效液相色谱法测定氯雷他定含量及其5种有关物质。方法 采用Agilent TC-C₁₈色谱柱(250 mm×4.6 mm，5 μm)，以乙腈-2%冰醋酸溶液为流动相，梯度洗脱，流速为1.0 mL·min^?1，检测波长为276 nm。结果 氯雷他定及其5种杂质分离良好。氯雷他定、地洛他定、N-甲基地洛他定、三环酮、杂质F、杂质I分别在3.2~106.7，0.97~ 58.3，0.59~35.5，0.58~34.5，0.59~35.4，0.82~49.3 μg·mL^?1内线性关系良好(r=0.999 4~0.999 9)。结论 本方法准确、灵敏、可靠，可用于氯雷他定原料药和制剂的质量研究和质量控制。

Abstract:

OBJECTIVE To establish an HPLC method for the determination of the content and related substances of loratadine. METHODS Agilent TC-C₁₈ column was used, the mobile phase consisted of acetonitrile-2% acetic acid solution, gradient elution. The flow rate was 1.0 mL·min^?1. The detection wavelength was 276 nm. RESUTLS Loratadine and its impurities could be separated with a good resolution. Loratadine, deslorata, N-methyldesloratadine, tricyclic ketone, impurity F and I were linear in the range of 3.2-106.7, 0.97-58.3, 0.59-35.5, 0.58-34.5, 0.59-35.4, 0.82-49.3 μg·mL^?1(r=0.999 4-0.999 9). CONCLUSION With good accuracy, sensitivity and reliability, the method can be applied to quality research and quality control of loratadine and its preparations.