复方甲诺尿素乳膏中甲硝唑和尿素含量的测定

The Determination of Metronidazole and Urea in Compound Metronidazole Urea Cream

目的:建立复方甲诺尿素乳膏中甲硝唑、尿素含量的测定方法,以期为复方甲诺尿素乳膏制剂的生产及质量控制提供依据。方法:采用高效液相色谱(HPLC)法,以甲醇-水(20∶80)为流动相,流速为1.0 mL·min^(-1),检测波长为320 nm,测定甲硝唑的含量;采用紫外分光光度法,在420 nm波长处测定吸光度,测定尿素的含量。结果:实验结果表明,甲硝唑在5.04~504.40μg·mL^(-1)浓度范围内,峰面积与浓度呈良好的线性关系,平均加样回收率为99.68%。尿素在15~90μg·mL^(-1)浓度范围内,吸光度与浓度呈良好的线性关系,加样回收率为97.88%。方法学中的稳定性、精密度、准确度、重复性试验的RSD均小于2.0%。结论:该测定方法简单、准确度及重现性良好,可用于复方甲诺尿素乳膏制剂的生产及质量控制。

Objecetive:To establish a method for determination of metronidazole and urea in compound metronidazole urea cream,so as to provide basis for the production and quality control of compound metronidazole urea cream.Methods:The HPLC method was adopted to determine the content of metronidazole.The mobile phase was methanol-water(20∶80),the flow rate was 1.0 mL·min-1 and the detection wavelength was 320 nm.The urea content was determined by ultraviolet spectrophotometry at 420 nm wavelength.Results:The experimental results showed that the linear range of metronidazole was 5.04~504.40μg·mL^(-1),and there was a good linear relationship between peak area and concentration.The average recovery was 99.68%.The absorbance had a good linear relationship with the concentration when the urea content range was 15~90μg·mL^(-1),and the recovery was 97.88%.The RSD of stability,precision,accuracy and repeatability tests in methodology were all less than 2.0%.Conclusion:The method is simple,accurate and reproducible,which can provide reference for the quality control of compound metronidazole urea cream.