RP-HPLC法测定盐酸异可利定片含量及有关物质

Determination of Content and Related Substances in Isolorydine Hydrochloride Tablets by RP-HPLC

目的:采用反相高效液相色谱法测定盐酸异可利定片的含量及其有关物质。方法:采用C18柱,以甲醇-磷酸盐缓冲液(取0.05 mol.L-1磷酸二氢钾溶液,用三乙胺调pH值至7.0)(60∶40)为流动相;流量为1.0 mL.min-1;检测波长267 nm。结果:杂质峰与主峰均能有效分离,盐酸异可利定在40.48～161.92μg.mL-1浓度范围内线性关系良好(r=0.9995),平均回收率为100.3%(n=9),RSD为0.7%。结论:本法简便、准确,专属性好,为提高盐酸异可利定片现行标准提供了参考依据。

Objective： To establish a method for determination of the related substances and the content of Isolorydine Hydrochloride Tablets by RP-HPLC. Method： The Cls column was used with the mixture of 0. 02 tool ·L-1 potassium dehydrogenate phosphate solu- tion （adjust pH value to 7.0 with triethylamine） and methanol （30： 70） as the mobile phase, the flow rate was 1.0 mL ·rain-1, UV detective wavelength was at 219 nm. Results： Isolorydine hydrochloride and its related substances can be completely separated. The linear range was 40. 48-161.92 μg · mL-l （r = 0. 9995 ）. The average recovery was 100. 3 % （ n = 9 ）, RSD = 0. 7 %. Conclusion： The method is simple, rapid, accurate, and valuable for determination of isolorydine hydrochloride and its related substances. It pro- vides reference basis for improving the current standards.