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目的使用HPLC法测定盐酸左西替利嗪分散片的含量及有关物质。方法 HypersilBDSC18色谱柱(150mm×4.6mm,um),流动相每升为0.02mol磷酸二氢铵(用磷酸调PH-3.2):乙腈(60:40)加入0.5%三乙胺,流速每分钟约为0.8mL,进样量20uL,检测波长230nm。结果盐酸左西替利嗪质量浓度在0.08～0.12g/L内与峰面积线性关系良好(r=0.9992),平均回收率为99.8%,RSD=0.56%(n=9)。结论 HPLC法的操作方法简单,结果准确可靠,重现性好,灵敏度高。
Objective To determine the content of levocetirizine hydrochloride dispersible tablets and its related substances by HPLC. Methods Hypersil BDSC18 column (150 mm × 4.6 mm, um) was used. The mobile phase was 0.02 mol ammonium dihydrogen phosphate (adjusted to pH 3.2 with phosphoric acid): acetonitrile (60:40) and 0.5% triethylamine 0.8mL, injection volume 20uL, detection wavelength 230nm. Results The concentration of levocetirizine hydrochloride in the range of 0.08-0.12 g / L was linear (r = 0.9992) with an average recovery of 99.8% and the RSD was 0.56% (n = 9). Conclusion The HPLC method has simple operation method, accurate and reliable results, good reproducibility and high sensitivity.