盐酸利福喷丁有关物质及含量测定方法的建立

Determination of Rifapentinum Hydrochloride and the Related Substances

目的:建立盐酸利福喷丁有关物质及含量的HPLC测定方法。方法:以C8为色谱柱,甲醇-乙腈-0. 0 75mol/L磷酸二氢钾溶液- 1 0mol/L枸橼酸溶液-水( 30∶30∶2 6∶4∶5)为流动相,流速为1 0mL/min ,柱温为30℃。检测波长为2 54nm。结果:在浓度为0 .1 3～0. 78mg/L范围内,本法线性关系良好,相关系数r =0 .9997,重复性试验RSD为1 0 % ,回收率为99 .8% (n =9)。结论:与现有方法比较,方法简便、准确,适用于该产品的质量检验分析。

Objective:To establish a HPLC method of determinating rifapentinum hydrochloride and the related substances. Methods: The separation was performed on a C_ 8 column. The mobile phase was methanol-acetonitrile-0.075 mol/L potassium dihydrogen-1.0 mol/L citric acid-water(30∶30∶26∶4∶5). The flow rate was 1.0 mL/min and the column temperature was 30℃. The detection wave length was at 254 nm. Results: The method showed good linear relationship( r =0.9997) and less variation (RSD 1.0% ). The average recovery was 99.8%, with RSD 0.3% ( n =9). Conclusion: In comparison with other exisiting methods, the method is simple and accurate, and can be used for the quality control of rifapentinum hydrochloride.