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目的:建立测定中间体中妥布霉素含量及主要杂质卡那霉素B的HPLC-ELSD方法。方法:采用Dikma Diamonsil C18(4.6mm×200mm,5μm)色谱柱;流动相为0.1mol·L-1三氟乙酸溶液,流速1.0mL.min-1;雾化管温度40℃,漂移管温度80℃,载气压力0.35MPa。结果:妥布霉素在0.220~2.198mg·mL-1范围内,峰面积与浓度呈较好的线性关系(r=0.9993),检测限和定量限分别为5μg·mL-1和13μg·mL-1。妥布霉素与主要氨基糖苷类杂质卡那霉素B可完全分离,分离度为2.153。结论:方法准确,可用于产品质量控制。
OBJECTIVE: To establish a HPLC-ELSD method for the determination of tobramycin and the main impurity kanamycin B in the intermediate. Methods: Dikma Diamonsil C18 (4.6mm × 200mm, 5μm) was used as the mobile phase. The mobile phase consisted of 0.1mol·L-1 trifluoroacetic acid solution and the flow rate was 1.0mL.min-1. The temperature of the tube was 40 ℃, ℃, carrier gas pressure 0.35MPa. Results: Tobramycin showed a good linearity (r = 0.9993) between the concentration range of 0.220 ~ 2.198 mg · mL-1 and the limit of detection and the limit of quantification were 5 μg · mL-1 and 13 μg · mL -1. Tobramycin and the main aminoglycoside impurity kanamycin B can be completely separated with a resolution of 2.153. Conclusion: The method is accurate and can be used for product quality control.