HPLC法测定注射用醋酸卡泊芬净的有关物质  

Determination of the Related Substances in Caspofungin Acetate for Injection by HPLC

作　　者：郭跃龙[1] 陈飞强[2] Guo Yuelong;Chen Feiqiang(Department of Pharmacy,Jiangsu Province Official Hospital,Nanjing 210024,China;Jiangsu Aosaikang Pharmaceutical Co.Ltd.)

机构地区：[1]江苏省省级机关医院药剂科,南京210024 [2]江苏奥赛康药业有限公司

出　　处：《中国药师》2020年第5期990-992,共3页China Pharmacist

摘　　要：目的:建立注射用醋酸卡泊芬净的有关物质测定方法,并用该方法对样品进行质量控制。方法:采用HPLC法,色谱柱:YMC Hydrosphere C18(150 mm×4.6 mm,3μm);流动相A:高氯酸与氯化钠混合溶液(取高氯酸1.0 ml和氯化钠0.75 g,加水溶解并稀释至1000 ml),流动相B:乙腈,梯度洗脱;柱温:25℃;流速:1.0 ml·min-1;检测波长:220 nm;进样量:50μl。结果:各杂质峰与醋酸卡泊芬净峰分离度良好,醋酸卡泊芬净、杂质A、杂质B、杂质D、杂质E、杂质I的进样浓度分别在0.075~1.995,0.059~1.586,0.031~0.835,0.043~0.173,0.037~0.299,0.018~0.438μg·ml-1范围内与各自峰面积呈良好的线性关系(r>0.9990)。杂质A、杂质B、杂质D、杂质E、杂质I的平均回收率分别为98.86%,99.74%,100.33%,100.86%,99.28%,RSD分别为3.37%,2.47%,3.07%,2.35%,2.82%(n=9)。结论:该方法专属性强,准确、快速,可用于注射用醋酸卡泊芬净的质量控制。Objective:To establish an HPLC method for determining the related substances in caspofungin acetate for injection.Methods:An HPLC method was established.A YMC Hydrosphere C18(150 mm×4.6 mm,3μm)column was used.The mobile phase A was mixed solution of perchloric acid and sodium chloride(1.0 ml perchloric acid and 0.75 g sodium chloride were dissolved and diluted to 1000 ml with water).The mobile phase B was acetonitrile with gradient elution.The column temperature was 25℃,the flow rate was 1.0 ml·min-1,the detection wavelength was set at 220 nm and the injection volume was 50μl.Results:The resolution of the related substances was acceptable.Caspofungin acetate,impurity A,impurity B,impurity D,impurity E and impurity I showed good linearity over the range of 0.075-1.995,0.059-1.586,0.031-0.835,0.043-0.173,0.037-0.299 and 0.018-0.438μg·ml-1(r>0.9990),respectively.The average recoveries of Impurity A,Impurity B,Impurity D,Impurity E,and Impurity I were 98.86%,99.74%,100.33%,100.86%and 99.28%,and RSDs were 3.37%,2.47%,3.07%,2.35%and 2.82%(n=9).Conclusion:The method is specific,accurate and rapid,and can be used for the quality control of caspofungin acetate for injection.

关 键 词：注射用醋酸卡泊芬净 有关物质 高效液相色谱法 

分 类 号：TQ460.7[化学工程—制药化工]