复方甲诺尿素乳膏中甲硝唑和尿素含量的测定

中国医药导刊 ›› 2021, Vol. 23 ›› Issue (11): 857-860.

复方甲诺尿素乳膏中甲硝唑和尿素含量的测定

霍旺1，赵振兴2，赵磊1,3*，马彧1*

1.四平市食品药品检验所，吉林四平 136001； 2.四平市中医院，吉林四平 136001； 3.长春中医药大学药学院，吉林长春 130117

收稿日期:2020-06-29 修回日期:2021-09-14 出版日期:2021-11-28 发布日期:2021-11-28

The Determination of Metronidazole and Urea in Compound Metronidazole Urea Cream

1. Siping City Institute for Food and Drug Control,Jilin Siping 136001,China； 2.Siping Hospital of Traditional Chinese Medicine,Jilin Siping 136001,China 3.School of Pharmacy, Changchun University of Traditional Chinese Medicine,Jilin Changchun 130117，China

Received:2020-06-29 Revised:2021-09-14 Online:2021-11-28 Published:2021-11-28

摘要/Abstract

摘要： 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5.04～504.40 μg·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15～90 μg·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。

关键词: font-size:medium, ">复方甲诺尿素乳膏；甲硝唑；尿素；高效液相色谱法；紫外分光光度法

Abstract: 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 5.04~504.40 μg·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 15~90 μg·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.

Key words: Compound metronidazole urea cream, Metronidazole ;Urea, HPLC;Ultraviolet spectrophotometry

中图分类号:

霍旺, 赵振兴, 赵磊, 马彧. 复方甲诺尿素乳膏中甲硝唑和尿素含量的测定[J]. 中国医药导刊, 2021, 23(11): 857-860.

HUO Wang, ZHAO Zhenxing , ZHAO Lei, MA Yu. The Determination of Metronidazole and Urea in Compound Metronidazole Urea Cream[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2021, 23(11): 857-860.

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