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目的 建立克林霉素乳膏剂的制备方法和质量标准。方法 采用HPLC测定盐酸克林霉素含量。结果 该法能很好分离被测组分与其它杂质 ,线性范围 5~ 2 5 0 0 μg(r =0 .9985 ) ,平均回收率 98.72 % ,RSD =1.5 2 %。结论此工艺简单 ,质量控制方法切实可行
Objective To establish the preparation method and quality standard of clindamycin cream. Methods The content of clindamycin hydrochloride was determined by HPLC. Results The method was able to separate the tested components and other impurities well with a linear range of 5-250 μg (r = 0.9985). The average recovery was 98.72% and RSD was 1.52%. Conclusion This process is simple, quality control method is feasible