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HPLC法测定匹多莫德含量及其有关物质
引用本文:朱永琴,景爱华,雷万军. HPLC法测定匹多莫德含量及其有关物质[J]. 河南科技大学学报(医学版), 2011, 29(1): 6-8
作者姓名:朱永琴  景爱华  雷万军
作者单位:1. 河南省食品药品检验所,河南郑州,450003
2. 河南科技大学医学技术与工程学院,河南洛阳,471003
基金项目:国家自然科学基金,河南省科技攻关计划项目,河南科技大学博士启动基金
摘    要:目的建立HPLC法测定匹多莫德分散片中匹多莫德含量及其有关物质的方法。方法色谱柱:Eclipse Plus C18(4.6 mm×250 mm,5μm);流动相:0.01 mol/L磷酸二氢钠溶液-甲醇-异丙醇(97∶2∶1);流速:1.0 mL/min;柱温:30℃;检测波长:210 nm。结果此方法在0.05~20.0 mg/mL范围内线性良好,回归方程为A=21624C+15621(r=0.9999),最小检出量为0.5 ng;匹多莫德与酸、碱、过氧化氢氧化产物均有良好的分离;供试品溶液在6 h内稳定。结论本方法简便、灵敏、专属性强,适用于匹多莫德分散片的质量控制。

关 键 词:高效液相色谱法  匹多莫德  有关物质

HPLC Determination of Pidotimod and Related Substances
ZHU Yong-qin,JING Ai-hua,LEI Wan-jun. HPLC Determination of Pidotimod and Related Substances[J]. Journal of Henan University of Science & Technology:Medical Science, 2011, 29(1): 6-8
Authors:ZHU Yong-qin  JING Ai-hua  LEI Wan-jun
Affiliation:ZHU Yong-qin,JING Ai-hua,LEI Wan-jun (Henan Province Food and Drug Institute,Zhengzhou 450003,China)
Abstract:Objective To establish HPLC method for determination of Pidotimod and its related substances. Methods Eclipse Plus C18(4.6 mm ×250 mm,5 μm)column was adopted with the mobile phase of 0.01 mol/L sodium dihydrogen phosphate solution-methanol-isopropyl alcohol(97∶2∶1)at a flow rate of 1.0 mL/min.The detection wavelength was set at 210 nm. Results The calibration curve was linear in the range of 0.05~20.0 mg/mL(r=0.9999).The limit of detection for the assay was 0.5 ng. Conclusion The method is simple,accurate and sensitive,and can be used to determine Pidotimod and its related substances.
Keywords:HPLC  Pidotimod  related substances  
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