药学研究2025，Vol.44Issue(7)：669-673,5.DOI:10.13506/j.cnki.jpr.2025.07.007
高效液相色谱联用电喷雾检测器解析利丙双卡因乳膏中聚氧乙烯(40)氢化蓖麻油的含量
Determination of polyoxyl(40)hydrogenated castor oil in lidocaine-prilocaine cream using high performance liquid chromatography coupled with charged aerosol detector
摘要
Abstract
Objective To establish a high-performance liquid chromatography coupled with charged aerosol detector(HPLC-CAD)method for the determination of polyoxyl(40)hydrogenated castor oil in lidocaine-prilocaine cream.Methods The sample was heated and extracted with anhydrous ethanol.The chromatographic column was Acclaim Surfactant Plus(4.6 × 150 mm,5 μm)column,the mobile phase was 0.1％(V/V)heptafluorobutyric acid-isopropanol(gradient elution).The parameters of CAD were as follows:atomization temperature was 50℃,sampling frequency was 10 Hz,and the filtration constant was 3.6 s.Quantification was conducted using the standard curve method.Results The method specificity was good.Solvent and other components did not interfere with the determination.Polyoxyl(40)hydrogenated castor oil showed a good linearity(r＞0.999 5)in the concentration range of 25～250 μg·mL-1.The recovery rate was in the range of 96.8％～101.6％at low,medium,and high concentrations,and the relative standard deviation(RSD)was 1.2％～2.3％.The RSDs of precision and stability were all less than 2％.We detected six batches of generic preparations using the established method.The results showed that the content of polyoxyl(40)hydrogenated castor oil was consistent with that of original preparations.Conclusion This method was simple,rapid,sensitive,and accurate,which provides technical support for the prescription analysis of lidocaine-prilocaine cream,fills the technical gap in the quantitative analysis of polyoxyl(40)hydrogenated castor oil,and lays a foundation for the enhancement of the quality standard of pharmaceutical excipient.关键词
高效液相色谱/电喷雾检测器/聚氧乙烯(40)氢化蓖麻油/利丙双卡因乳膏Key words
High-performance liquid chromatography(HPLC)/Charged aerosol detector(CAD)/Polyoxyl(40)hydrogenated castor oil/Lidocaine-prilocaine cream分类
医药卫生引用本文复制引用
徐晓茜,周佳彤,文松松,王雪,牛冲,郭常川,张连义,徐玉文,向宇..高效液相色谱联用电喷雾检测器解析利丙双卡因乳膏中聚氧乙烯(40)氢化蓖麻油的含量[J].药学研究,2025,44(7):669-673,5.基金项目
国家自然科学基金项目(No.81573606、81973486) （No.81573606、81973486）
泰山产业领军人才工程专项经费项目(No.tscx202306073) （No.tscx202306073）
