HPLC法测定盐酸左西替利嗪有关物质

Determination the Related Substance in Levocetirizine Dihydrochloride by HPLC

建立盐酸左西替利嗪中有关物质的HPLC测定方法。方法:采用Agilent SB-C18色谱柱(4.6 mm×25 cm,5μm)对降解杂质和工艺杂质进行定量分析,以乙腈和0.7%磷酸溶液为流动相低压梯度洗脱,流速1.2 m L/min,检测波长为230 nm。结果:该色谱方法可检测到盐酸左西替利嗪的9种有关物质,主峰与各杂质峰间能达到良好分离;3批样品有关物质测定结果显示,总杂质含量低于0.4%。结论:方法学验证表明,本法可作为盐酸左西替利嗪有关物质质量控制的方法。

To establish a HPLC method of the concent and related substances of Levocetirizine Dihydrochloride.Methods：RP-HPLC was adopted to determine Levocetirizine Dihydrochloride related substances,quantitative analysis of degradation and process impurities using an Agilent SB-C18 column（4.6 mm×25 cm,5μm） with a low pressure gradient elution system of acetonitrile-0.7%phosphoric acid,while the flow rate was1.2m L/min and the detection wavelengh was 230 nm.The result shows the related substance in Levocetirizine Dihydrochloride can be detected by this chromatographic method,related substances were completely separated from the main constituents;according to the result,the related substance of three bacthes were lower than0.4%. The conclusion shows that this method is proved by the validation that it can be used for the related substance control of Levocetirizine Dihydrochloride.