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目的:建立HPLC法测定交沙霉素含量的方法并与微生物检定法结果相比较。方法:采用RP-HPLC法,以C18为固定相:流动相:水-乙腈(45:55),用三乙胺调节pH值为8．0;检测波长:232 nm。结果:在0．1-1．4 mg·ml-1的浓度范围内呈良好线性关系。结论:本方法色谱系统简单,可靠。经与微生物检定法结果比较,结果准确可靠,精密度高。且能将交沙霉素与其各杂质组分实现良好分离,测定结果更加准确。
OBJECTIVE: To establish a HPLC method for the determination of josamycin and to compare it with the results of microbiological assay. Methods: RP-HPLC was used with C18 as stationary phase. The mobile phase was water-acetonitrile (45:55). The pH was adjusted to 8.0 with triethylamine. The detection wavelength was 232 nm. Results: There was a good linear relationship in the concentration range of 0.1-1.4 mg · ml-1. Conclusion: The chromatographic system of this method is simple and reliable. Compared with the results of microbial test results, the results are accurate and reliable, high precision. And josamycin and its impurity components to achieve a good separation, the measurement results more accurate.