中国药房2017，Vol.28Issue(36)：5157-5159,3.DOI:10.6039/j.issn.1001-0408.2017.36.31
HPLC法测定泊沙康唑原料药中的有关物质
Determination of Related Substance in Posaconazole Raw Material by HPLC
李晓琴 1李楠 1张晓 1刘宇 1贾爱琼 1刘瑜1
作者信息
- 1. 成都大学四川抗菌素工业研究所,成都610052
- 折叠
摘要
Abstract
OBJECTIVE:To establish a method for the determination of related substance in posaconazole raw material.METHODS:HPLC method was adopted.The separation was performed on Zorbax Eclipse Plus C18 column with mobile phase consisted of 0.05 mol/L ammonium acetate solution (pH adjusted to 4.0 using acetic acid)-acetonitrile (gradient elution) at the flow rate of 1.0 mL/min.The detection wavelength was set at 262 ran,and the column temperature was 30 ℃.The sample size was 20 μL.RESULTS:The linear range of intermediate I was 0.05-5.0 μg/mL (r=0.999 9);the limit of quantitation was 0.05 μg/mL,the limit of detection was 0.013 μg/mL;RSDs of precision test,stability test and repeatability test were lower than 2.0％;the recoveries was 98.00％-101.69％ (RSD=1.22％,n=9).CONCLUSIONS:The method is simple,accurate and suitable for the determination of related substance in posaconazole raw material.关键词
泊沙康唑/原料药/有关物质/高效液相色谱法Key words
Posaconazole/Raw material/Related substances/HPLC分类
医药卫生引用本文复制引用
李晓琴,李楠,张晓,刘宇,贾爱琼,刘瑜..HPLC法测定泊沙康唑原料药中的有关物质[J].中国药房,2017,28(36):5157-5159,3.
