摘要
目的：采用HPLC—NQAD（水凝聚核粒子计数蒸发光检测器）法和HPLC—ELSD（中国药典方法）法测定硫酸卡那霉素注射液的含量，并对2种方法进行比较。方法：采用AgilentSBC18色谱柱（250mm×4．6mm，5μm），流动相为0．2％三氟乙酸溶液-甲醇（80：20，V/V）。结果：卡那霉素进样量在195．2～1952ng范围内具有良好的线性，相关系数为0．9991，卡那霉素检出限为19．4ng，卡那霉素样品的加样回收率为99．7％（n=9）。结论：本方法具有较高的准确度、精密度和灵敏度，方法简便，可用于卡那霉素的检测分析。该方法较药典方法有较高的灵敏度，且峰面积与浓度直接线性响应。
Objective：To determine the content of kanamycin sulfate injection by methods of HPLC -NQAD（ nano quantity analyte detector）and HPLC -ELSD （evaporative light scattering detector, the method as described in the Chinese pharmacopoeia） and compare the two methods. Methods： The chromatographic separation was achieved with Agilent SB C18 column （ 250 mmx 4. 6 ram, 5μm） by 0. 2% trifluoroacetic acid - methanol （ 80： 20, V/V）. Results： The calibration curve of kanamycin was linear in the range of 195.2 -1952 ng（ r =0. 9991 ） ,the detection limit of kanamycin was 19.4 ng,the average recovery was 99.7%. Conclusion：The method established is accurate, sensi- tive, and reliable for the determination of kanamycin sulfate injection. The method has higher sensitivity compared with the pharmacopoeia method, and the peak area has a direct response with concentration.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2014年第4期644-648,共5页
Chinese Journal of Pharmaceutical Analysis
基金
化学新药质量标准研究与评价技术平台(2011ZX09303-001)
