Study on Quality Control Method of Compound Lidocaine Cream / 中国药房

ABSTRACT

OBJECTIVE： To develop a HPLC method for the determination of the contents of lidocaine and prilocaine in compound lidocaine cream as a quality control means.METHODS： Lidocaine and prilocaine in compound lidocaine cream were determined by high-performance liquid chromatography on C18 column with the detection wavelength at 254nm.The mobile phase was 0.5％ ammonium dihydrogen phosphate(pH=7)-methanol(20∶ 80).RESULTS： The calibration curves of both lidocaine and prilocaine were linear within the concentration range of 130～250μ g/ml(r=0.9 996).The recovery rates of lidocaine and prilocaine were 99.05％ and 99.27％ respectively， RSDs were 0.67％ and 1.15％ ， intra-day RSDs 0.81％ and 1.45％ ， inter-day RSDs 0.55％ and 0.63％ respectively.CONCLUSION： The method was sensitive， stable and accurate.It can be used to determine and control the quality of compound lidocaine cream.