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目的建立依普利酮片有关物质和含量测定的HPLC测定方法。方法采用Sepax GP-C18(4.6mm×250 mm,5μm)色谱柱,以10mmol/l醋酸铵为流动相A,乙腈-甲醇(1∶1)为流动相B,241nm波长检测,线性梯度洗脱进行有关物质检查,等度洗脱进行含量测定,LC-MS/MS法鉴定有关物质。结果依普利酮的线性范围为2~250μg/ml(r=1.000),平均回收率为99.9%,RSD为0.9%,检测限为0.05μg/ml,精密度与24h稳定性RSD均小于2%;依普利酮与强制降解产物分离度良好。结论本方法简便、灵敏、重复性好,结果准确可靠。可作为依普利酮片含量测定和有关物质的检查方法,其主要降解杂质为水解物。
Objective To establish a HPLC method for the determination of related substances and contents of eplerenone tablets. Methods The mobile phase A was acetonitrile-methanol (1: 1), acetonitrile-methanol (1: 1) was used as mobile phase B at a resolution of 241 nm with a Sepax GP-C18 column (4.6 mm × 250 mm, Carry out the relevant material inspection, isocratic elution to determine the content, LC-MS / MS method to identify the relevant substances. Results The linear range of eplerenone was 2 ~ 250μg / ml (r = 1.000), the average recovery was 99.9%, the RSD was 0.9% and the detection limit was 0.05μg / ml. The RSDs of precision and 24h stability were less than 2 %; Eplerenone and forced degradation products separation is good. Conclusion The method is simple, sensitive, reproducible and accurate. Eplerenone tablets can be used as content determination and related substances inspection methods, the main degradation of impurities for the hydrolysis.