摘要
目的建立测定复方氧化锌鱼肝油软膏中维生素A含量的高效液相色谱法。方法采用正己烷提取样品中的维生素A,色谱柱为Waters silica柱(250 mm×4.6 mm,5μm),流动相为正己烷-异丙醇(997∶3,V/V),流速为1.0 mL/min,检测波长为325 nm,柱温为30℃,进样量为10μL。结果维生素A醋酸酯的活性单位浓度在1.43~28.60 IU/mL范围内与峰面积线性关系良好(r=0.9999,n=5);检测限为30μg/g,定量限为100μg/g;精密度、稳定性、重复性试验结果的RSD均小于3.0%;加样回收率为95.76%,RSD为3.58%(n=6)。3批样品中维生素A的含量分别为760.34,794.62,747.67 IU/g。结论该方法操作简便、重复性好、结果准确,可用于复方氧化锌鱼肝油软膏中维生素A的含量测定。
Objective To establish a high-performance liquid chromatography(HPLC)method for the content determination of vitamin A in Compound Cod Liver Oil and Zinc Oxide Ointment.Methods Vitamin A was extracted from the sample by n-hexane,the chromatographic column was Waters silica column(250 mm×4.6 mm,5μm),the mobile phase was n-hexane-isopropanol(997∶3,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 325 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The linear range of active unit concentration of vitamin A acetate was 1.43-28.60 IU/mL(r=0.9999,n=5).The limit of detection was 30μg/g,and the limit of quantification was 100μg/g.The RSDs of precision,stability,and repeatability test results were all lower than 3.0%.The recovery rate of vitamin A was 95.76%with an RSD of 3.58%(n=6).The content of vitamin A in the three batches of samples was 760.34,794.62,and 747.67 IU/g,respectively.Conclusion The method is simple,reproducible and accurate,which can be used for the content determination of vitamin A in Compound Cod Liver Oil and Zinc Oxide Ointment.
作者
苗会娟
徐艳梅
王茉莉
郝丽娟
高燕霞
MIAO Huijuan;XU Yanmei;WANG Moli;HAO Lijuan;GAO Yanxia(Hebei Institute for Drug and Medical Device Control·NMPA Key Laboratory for Quality Control and Evaluation of Generic Drug,Shijiazhuang,Hebei,China 050200)
出处
《中国药业》
CAS
2024年第5期80-82,共3页
China Pharmaceuticals
基金
河北省卫生健康委员会2021年度河北省医学科学研究课题计划[20211194]