HPLC测定扎鲁司特片中扎鲁司特的含量

Content Determination of Zafirlukast in Zafirlukast Tablets by HPLC

摘要: 目的建立高效液相色谱法测定扎鲁司特片中扎鲁司特的含量。方法采用Zorbax Eclipse Plus C₁₈柱(250 mm×4.6 mm，5 μm)，流动相为0.05 mol·L^-1磷酸二氢钾溶液 (用磷酸调节pH至3.0)-乙腈(25∶75)，流速为1.0 mL·min^-1，检测波长为242 nm。结果扎鲁司特在20~70 μg·mL^-1内与峰面积呈良好线性关系(r=0.999 7，n=6)，平均回收率为100.1%，RSD为0.61%。结论该方法简便，准确，重复性好，可用于扎鲁司特片中扎鲁司特的质量控制。

Abstract: OBJECTIVE To establish a method for the content determination of zafirlukast in Zafirlukast Tablets by HPLC. METHODS Zorbax Eclipse Plus C₁₈(250 mm×4.6 mm，5 μm) column was used with 0.05 mol·L^-1 potassium dihydrogen phosphate (adjust pH to 3.0 with phosphoric acid)-acetonitrile (25∶75) as mobile phase. The flow rate was 1.0 mL·min^-1 and the detection wavelength was 242 nm. RESULTS The linear rang of zafirlukast was 20-70 μg·mL^-1(r=0.999 7, n=6), the average recovery was 100.1%, RSD was 0.61%. CONCLUSION The method is simple, reliable, accurate and can be used in the quality control of zafirlukast in Zafirlukast Tablets.