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分别选用3,5-二硝基苯甲酰氯和2,4-二硝基氟苯作衍生化试剂,柱前衍生,采用高效细粒度短柱(4.6mm×3.3cm,3μm)快速分离,二极管阵列紫外检测器检测,外标法定量,建立了核糖霉素及杂质新霉胺的两种RP-HPLC快速测定方法,分析时间均低于5min。对方法的重现性、灵敏度、准确度、线性范围等指标进行考察,结果均令人满意。运用统计配对t检验法对两种方法的测定结果进行相关分析,结果表明:方法之间无显著性差异。
3,5-dinitrobenzoyl chloride and 2,4-dinitrofluorobenzene were selected as derivatization reagents respectively and pre-column derivatization was carried out, and they were quickly separated by high-performance fine-grained short columns (4.6 mm × 3.3 cm, 3 μm) , Diode array detector UV detection, external standard method of quantification, established two methods of rapid determination of ribostamycin and impurities neamine amines, analysis time less than 5min. The method reproducibility, sensitivity, accuracy, linear range and other indicators were investigated, the results are satisfactory. The statistical paired t test was used to analyze the results of the two methods. The results showed that there was no significant difference between the methods.