来曲唑原料药的含量测定及有机杂质分析

Content Determination and Organic Impurity Analysis of Letrozole APIs

来曲唑是乳腺癌患者临床治疗中的基本药物,随着加工工艺的不断改进,来曲唑原料药的含量和杂质也随之发生改变。为更好地保证临床用药的质量和疗效,研究构建了基于高效液相色谱法(High Performance Liquid Chromat ography;HPLC)的来曲唑原料药含量和有机杂质测定方法。试验结果显示,在样品溶液浓度为8.00μg/mL至12.50μg/mL之间的条件下,得到的来曲唑试验样品的来曲唑的平均回收率分别为99.9%、99.7%以及99.8%,符合回收标准,即来曲唑含量测定方法有较好的精确度。由此说明,研究设计的来曲唑原料药含量测定和有机杂质分析方法是可行的,适合对其进行含量测量和有机杂质检测。

Letrozole is the basic drug for clinical treatment of breast cancer patients.With the continuous improvement of processing technology,the content and impurities of letrozole APIs also change.To better ensure the quality and efficacy of clinical medication,a method based on high performance liquid chromatography(HPLC)for determining the content and organic impurities of letrozole APIs is developed.The experimental results show that under the conditions of sample solution concentrations of 0.8,0.1,and 1.2,the average recoveries of letrozole in the letrozole test samples are 99.9%,99.7%,and 99.8%respectively,which can meet the recovery standards.Therefore,the method for determining the content of letrozole has good accuracy.This indicates that the research designed method for determining the content of letrozole APIs and analyzing organic impurities is feasible and suitable for content measurement and organic impurity detection.