| 柱前衍生化高效液相色谱法检测硫酸阿米卡星注射液中卡那霉素含量的改进 |
| 投稿时间：2012-12-17 修订日期：2013-04-08 点此下载全文 |
| 引用本文：张明媛,常靓,刘长海,陈秋芬,张军东,陆峰.柱前衍生化高效液相色谱法检测硫酸阿米卡星注射液中卡那霉素含量的改进[J].药学实践杂志,2013,31(5):344~346 |
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| 基金项目:上海市科学技术委员会科研计划项目(11DZ920905). |
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| 中文摘要:目的 改进柱前衍生化-HPLC方法用于定量测定硫酸阿米卡星注射液中已知杂质卡那霉素。方法 采用更低浓度的样品检测溶液,色谱柱:Agilent ZORBAX SB-C18柱 (4.6 mmá150 mm,5 μm);流动相:0.27%磷酸二氢钾溶液(用2.2%的氢氧化钾溶液调节pH值至6.5)-甲醇(30:70);检测波长:340 nm;进样量:50 μl;流速:1.0 ml/min;柱温:30℃。结果 卡那霉素在2~80 μg/ml(r=0.999 8)浓度范围内呈线性关系,平均回收率为(93.08±9.65)%,样品稳定性提高。结论 本法专属性强,灵敏度高,准确度好,为硫酸阿米卡星注射液的安全性评价提供了一个新的角度。 |
| 中文关键词:卡那霉素 硫酸阿米卡星 高效液相色谱法 稳定性 柱前衍生化 |
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| An improvement method of pre-column derivatization LC-UV for assaying kanamycin in amikacin sulfate injection |
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| Abstract:Objective To develop and evaluate the stable method for the determination of impurity D (kanamycin) in amikacin sulfate injection with pre-column derivatization HPLC. Methods The lower concentration of sample was used. An Agilent ZORBAX SB-C18 column(4.6 mmá150 mm, 5 μm) was used for the chromatographic separations. The mobile phase consisted of mixture of a 2.7% solution of potassium dihydrogen phosphate adjusted to pH 6.5 (using 22 g/L solution of potassium hydroxide) and methanol (30:70, v/v). The flow rate was 1 ml/min. A 50μl volume of each sample was injected. The column temperature was maintained at 30℃. Results The linear range of kanamycin was 2~80 μg/ml (r=0.999 8), accuracy was (93.08±9.65)%. Conclusions The development method was successfully applied to the quantitative determination of kanamycin in amikacin sulfate injection and also offered a new perspective for safety evaluation of amikacin sulfate injection. |
| keywords:kanamycin amikacin sulfate HPLC stability indicating pre-column derivatization |
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