Determination of polyoxyl(40)hydrogenated castor oil in lidocaine-prilocaine cream using high performance liquid chromatography coupled with charged aerosol detector
XU Xiaoxi
ZHOU Jiatong
WEN Songsong
WANG Xue
NIU Chong
GUO Changchuan
ZHANG Lianyi
XU Yuwen
XIANG Yu
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.
Keywords：High-performance liquid chromatography(HPLC)Charged aerosol detector(CAD)Polyoxyl(40)hydrogenated castor oilLidocaine-prilocaine cream
Publication Date：2025-07-30
Online Publishing Date：2025-08-21(First online date of this platform, not the publication date of the document)
Pages：5( 669-673 )