| 华小懿,沈于兰,杨敏智.离子色谱法测定米诺膦酸及其片剂的含量[J].中国药品标准,2019,20(2):138-142 |
| 离子色谱法测定米诺膦酸及其片剂的含量 |
| The Content Determination of Minodronic Acid and Its Tablets by Ion Chromatography |
| 投稿时间：2019-01-17 修订日期：2019-04-02 |
| DOI： |
| 中文关键词: 离子色谱 米诺膦酸 米诺膦酸片 含量测定 |
| 英文关键词: ion chromatography minodronic acid minodronic acid tablet content determination |
| 基金项目:江苏省食品药品监督管理局科研项目(20170217) |
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| 中文摘要: |
| 目的：建立离子色谱法测定米诺膦酸及其片剂中米诺膦酸的含量。方法：采用IonPac AS23阴离子交换色谱柱分离,淋洗液为3 mmol.L-1草酸溶液,流速为1.0 mL.min-1,柱温为30℃,进样量为25 μL,检测方式为电导检测器。结果：米诺膦酸在9.50~380.08 μg.mL-1范围内线性关系良好(r=1.0000)；原料药和片剂的平均加样回收率分别为101.0%(RSD为0.4%,n=9)和98.8%(RSD为1.2%,n=9)。结论：该方法准确、灵敏、简便,可用于米诺膦酸原料药及其制剂中米诺膦酸的含量测定。 |
| 英文摘要: |
| Objective: To establish an ion chromatography method to determine the content of minodronic acid in minodronic acid and its tablets. Methods: The separation was performed on an IonPac AS23 anion exchange column eluted with 3 mmol.L-1 oxalic acid solution. The flow rate was 1.0 mL.min-1. The column temperature was 30℃. The injection volumn was 25 μL. The detector was conductivity detector. Results: The linear range of minodronic acid was 9.50 ~380.08 μg.mL-1 (r=1.0000)．The average recoveries of the drug substance and the tablet was 101.0% with RSD as 0.4% (n=9) and 98.8% with RSD as 1.2% (n=9). Conclusion: The method is accurate, sensitive and simple, which provides a new reliable analytical method for the content determination of minodronic acid and its tablets. |
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