Preparation and Quality Control of Compound Azelaic Acid Cream

OBJECTIVE:To prepare compound azelaic acid cream and to establish its quality control method.METHODS:Compound azelaic acid cream was prepared with vitamin E and azelaic acid as principal agents;the content of vitamin E was determined by HPLC while the contents of azelaic acid and vitamin C were determined by volumetry.RESULTS:The prepared cream was well-spread and its character,identification,and tests etc were all in line with the related standards stated in China Pharmacopeia(2005 edition).The linear range of vitamin E was 124.5～ 415.0μ g · mL-1(r=0.999 9),with average recovery at 98.53%(RSD=1.01%).The average recovery for azelaic acid was 100.02%(RSD=0.65%)and that for vitamin C was 98.99%(RSD=0.97%).CONCLUSION:The preparation had reasonable formulation,simple preparation technology and stable and controllable quality.