摘要
目的建立复方克林霉素乳膏中盐酸克林霉素和甲硝唑的含量测定方法。方法采用HPLC对盐酸克林霉素和甲硝唑的含量进行测定。盐酸克林霉素:色谱柱为ZORBAX SB-C18(4.6×150 mm,5μm),以磷酸二氢钾-乙腈(55∶45)为流动相,检测波长为210 nm,柱温为25℃,流速1.0 ml/min;甲硝唑:色谱柱为ZORBAX SB-C18(4.6×150 mm,5μm),以甲醇-水(20∶80)为流动相,检测波长为320 nm,柱温为30℃,流速1.0 ml/min。结果复方克林霉素乳膏中盐酸克林霉素含量在90.2~901.6μg/ml范围内线性关系良好(r=0.9999),平均回收率102.3%(n=6),精密度RSD=0.53%;甲硝唑含量在12.9~414.0μg/ml范围内线性关系良好(r=0.9999),平均回收率103.1%(n=6),精密度RSD=0.01%。结论该方法简单,结果准确、重现性好,可作为该制剂的质量控制方法 。
Objective To establish an HPLC method for the determination of clindamycin hydrochloride, metronidazol in Compound Kelinmeisu Cream. Methods The content of clindamycin hydrochloride,metronidazol were determined by HPLC. Clindamycin hydrochloride：the Column was ZORBAX SB-C18 （4.6×150mm,5μm）, monopotassium phosphate-acetonitrile （55：45） as mobile phase,the detection wavelength was 210nm. the temperature of column was 25-C and the flow rate was 1.0ml/min. Metronidazol：the Column was ZORBAX SB- C18 （4.6×150mm,5μm）,methul alcohol-water （20：80） as mobile phase,the detection wavelength was 320nm,the temperature of column was 30℃ and the flow rate was 1.0ml/min. Results The calibration curve of clindamycin hydrochloride was linear over the range of 90.2-901.6μg/ml （r=0.9999）,the average recovery rate was 102.3%（n= 6）,RSD=0.53%;the calibration curve of metronidazole was linear over the range of 12.9-414.0p, g/ml（r=0.9999）,the average recovery rate was 103.1%（n=6）,RSD=0.01%. Conclusion The method is performed easyly with accurate results and good reproducibility. It can be used effectively for the quality control of above preparation.
出处
《实用医药杂志》
2017年第12期1111-1114,共4页
Practical Journal of Medicine & Pharmacy
基金
军队医疗机构制剂标准提高科研专项课题计划(No.14ZJZ01-2)
