摘要
目的建立米屈肼原料的有关物质和含量的测定方法方法采用反相高效液相色谱-蒸发光检测方法,色谱柱Inertsil CN-3(4.6 mm×250 mm,5μm),流动相:乙腈-水(20:80),Alltech EISD 2000检测器:检测温度90℃,气流速度2.5 mL·min-1。结果米屈肼在10.3-814.4 μg·mL-1内,相关系数r=0.999 7,方法的日内和日间精密度分别为0.41%和1.63%。结论方法简便,准确,重复性好,适用于米屈肼原料药有关物质、降解产物的测定和含量测定。
OBJECTIVE: To establish a method for the determination of mildronate and related substances. METHODS: Using HPLC-ELSD method, the related substances were separated on a CN - 3 column(4.6 mm × 250 mm, 5 μm, Inertsil), and the mobile phase consisted of water and acetonitrile(80:20). The ELSD detection temperature was 90 °C, and the gas rate was 2.5 mL·min-1. RESULTS: The liner range was 10.3-814.4 μg·mL-1. The RSD of precision was 0.41% for intra-run validation and 1.63% for inter-run validation. CONCLUSION: This method was simple and accurate to determine mildronate and the related substance.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2005年第11期864-866,共3页
Chinese Pharmaceutical Journal
