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庆大霉素是由绛红色小单孢菌和棘状小单孢菌发酵产生的氨基苷类抗生素。《中国药典》1995年版采用高效液相色谱法测定,用面积归一法计算硫酸庆大霉素C组分的含量。我们在执行此方法的过程中发现在不同的实验条件下,结果重现性较差,误差达3％以上。本文通过抽样五批,分别在市药检所、市第六制药厂实验室测定,分析峰面积归一法计算C组分含量误差原因。1 材料与方法1.1 仪器 均为SP8810型高效液相色谱仪。1.2 条件 色谱条件与系统适用性试验均符合《中国药典》
Gentamycin is an aminoglycoside antibiotic produced by the fermentation of Micromonospora crenica and Micromonospora sp. “Chinese Pharmacopoeia” 1995 edition using high performance liquid chromatography determination, the area normalization method for the calculation of gentamicin sulfate C component content. In the course of carrying out this method, we found that under different experimental conditions, the results were poor with a reproducibility error of more than 3%. In this paper, five batches of samples were obtained, respectively, in the city drug seized by the city, the sixth pharmaceutical laboratories measured peak area normalization method to calculate the C component content error causes. 1 Materials and Methods 1.1 Instruments are SP8810-type high performance liquid chromatography. 1.2 Conditions Chromatographic conditions and system suitability tests are in line with “Chinese Pharmacopoeia”