Preparation and Quality Control of Limonin Creams

Abstract:

Objective: To prepare limonin creams and investigate its quality stability. Method: Creams was prepared with limonin as raw material,HPLC was adopted to determined the content and related substances of limonin,chromatographic conditions were as follows:Zorbax SB-C₁₈ column(4.6 mm×150 mm,5 μm),Zorbax SB-C₁₈ guard column(4.6 mm×12.5 mm,5 μm),mobile phase of water-acetonitrile(42:58),detection wavelength 207 nm,flow rate 1.0 mL·min^-1,column temperature at room temperature,injection volume 20 μL,stability of three batches of limonin creams were carried out. Result: Limonin creams showed milky white,its identification and inspection items were in line with relevant regulations,the linear range of limonin was 20.26-101.3 mg·L^-1 with average recovery of 99.6%(RSD 0.68%).The mass fraction of limonin in three creams samples was 100.4%-101.6%,quality of samples was stable in different environments except in high humidity or high temperature,where volume would be slightly increased or decreased. Conclusion: This preparation technology was simple and controllable,it should be saved in cool and dry place.