高效液相色谱法测定复方曲尼司特片中曲尼司特含量

Content Determination of Tranilast in Compound Tranilast Tablets by HPLC

目的建立测定复方曲尼司特片中曲尼司特含量的高效液相色谱（HPLC）法。方法色谱柱为XBridge C_（18）柱（250 mm×4.6 mm,5μm）,以甲醇-0.02 mol/L磷酸二氢钾溶液（63∶37,用磷酸调pH至4.6）为流动相,流速为1.0 mL/min,检测波长为333 nm。结果曲尼司特质量浓度在32.66~130.64μg/mL范围内与峰面积积分值线性关系良好,平均回收率为99.67%,RSD为0.33%（n=6）。结论该方法简便准确、重复性好,适用于复方曲尼司特片中曲尼司特的含量测定。

Objective To establish an HPLC method for the content determination of tranilast in Compound Tranilast Tablets.Methods The XBridge C_（18） column（ 250 mm × 4. 6 mm,5 μm） was used with methanol- 0. 02 mol / L potassium dihydrogen phosphate solution（ 63 ∶ 37）（ adjusting pH to 4. 6 with phosphoric acid） as the mobile phase. The flow rate was 1. 0 mL / min and the detection wavelength was 333 nm. Results There was a good linear relationship when the content of tranilast was within the range of 32. 66-130. 64 μg / mL. The average recovery was 99. 67% and the RSD was 0. 33%（ n = 6）. Conclusion The method is simple and accurate with good reproducibility,which could be used for the analysis of tranilast in Compound Tranilast Tablets.