摘要
目的:建立反相高效液相色谱法测定IDPα晶型的含量及其有关物质。方法:采用梯度洗脱(线性梯度)方法,色谱柱:Diamonsil C18(250mm×4.6mm,5μm);流动相:流动相A为乙腈,B为水;检测波长为228nm;流速:1.2mL·min-1。结果:在该条件下,IDPα晶型主峰与有关物质得到了很好的分离;在10-80μg.mL-1范围内,浓度与相应的峰面积呈良好的线性关系(r=0.9999);最低定量限和最低检测限分别为14ng和4ng。结论:本方法简便、准确,专属性好,可用于质量控制。
Objective:To establish an RP-HPLC method for the determination of IDP α polymorph and its related substances.Methods:The HPLC method was conducted on a Diamonsil C18 column(250 mm×4.6 mm,5 μm)and UV detector at 228 nm.The gradient elution was used with a flow rate of 1.2 mL·min-1.The mobile phase was acetonitrile(A)and water(B).Results:Using this method,IDP α polymorph and its related substances were well separated.The linear ranges were 10-80 μg·mL-1(r=0.9999);the limit of detection and the limit of quantification were 14 ng and 4 ng,respectively.Conclusion:The proposed method is simple,accurate and specific for the quality control of IDP α polymorph.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2010年第6期1052-1054,共3页
Chinese Journal of Pharmaceutical Analysis
基金
国家自然基金项目(NO.20672143)
国家科技重大专项"重大新药创制"
综合性新药研究开发技术大平台(2009ZX09301-002)