摘要
目的建立辅料乳糖的HPLC-RID检测方法。方法色谱柱为Boston Green Amino氨基键合硅胶柱(250 mm×4.6mm,5μm),流动相为乙腈-水(70?30),体积流量1.0 m L/min,柱温45℃;检测器为示差折光检测器,检测器温度40℃,进样量10μL。结果乳糖在0.2~5.0 mg/m L范围内线性关系良好(r≥0.999 8),检测限为0.06 mg/m L,平均回收率为99.6%,相对标准偏差为0.7%。结论该方法专属性好、操作简便、快速准确,适用于辅料乳糖的含量测定。
Objective To establish a method for determination of accessories lactose by HPLC-RID. Methods Boston Green Amino-NH2 column （250 mm ×4.6 mm, 5 μm） was used. The mobile phase was acetonitrile-water （70：30）. The flow rate was 1.0 mL/min. The column temperature was 45 ℃, the detector temperature was 40 ℃ and the injection volume was 10 μL. Results Lactose showed good linearity in the range of 0.2--5.0 mg/mL （r≥0.999 8）. The detection limit was 0.06 mg/mL. The average recovery was 99.6% and the relative standard deviation was 0.7%. Conlusion The method is specific, convenient, fast and accurate, which can be used for determination of accessories lactose.
出处
《药物评价研究》
CAS
2017年第7期942-945,共4页
Drug Evaluation Research
