复方林可霉素乳膏质量标准研究

Quality standard for compound lincomycin cream

目的:建立复方林可霉素乳膏的质量控制方法。方法:对氯化物进行鉴别,采用高效液相色谱法测定其中盐酸林可霉素的含量。结果:盐酸林可霉素在1.0～3.0 mg/ml范围内线性关系良好(,r=0.991 6,n=5),平均回收率为101.58%,RSD为1.29%(n=9)。结论:该方法简便准确、重复性好,可有效控制制剂质量。

Objective：To establish the quality standard for compound lincomycin cream.methods：chloride was identified,and the content of lincomycin was determined by HPLC.Results：A linearity was obtained from 1.0 mg to 3.0 mg of lincomycin in compound lincomycin cream with a good correlation coefficient（r=0.991 6,n=5）.The average recovery was 101.58% with 1.29% of RSD（n=9）.Conclusion：The method is reliable,accurate and can be used for quality control of compound lincomycin cream.