注射用阿莫维酸钾的HPLC分析及稳定性研究  

Study on Determination and Stability of Amoxicillin Sodium and Clavulanate Potassium for Injection by HPLC

作　　者：张哲峰[1,2] 鹿颐[1,2] 梁贵键[1,2] 王元度 刘炜[1,2] 

机构地区：[1]河北省药品检验所 [2]空军总医院

出　　处：《药物分析杂志》1996年第6期366-369,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：国家自然科学基金

摘　　要：本文以硼砂缓冲液（０．０８ｍｏｌ／Ｌ，ｐＨ４．０）—甲醇（９５５）为流动相，在ＯＤＳ柱上分析注射用阿莫维酸钾，２２０ｎｍ检测。各成分线性关系良好，阿莫西林（ＡＭＯ）及克拉维酸（ＣＬＶ）回收率分别为（９９．９０±０．１８）％和（９９．７６±０．２１）％。运用线性升温法考察了本品稳定性，ＡＭＯ的室温降解速率常数Ｋ２５℃＝２．２６×１０－６／ｈ，ｔ０．９＝３．４年；ＣＬＶ为Ｋ２５℃＝３．６０×１０－８／ｈ，ｔ０．９＝５．４年。并证实本品的水溶液浓度越大，越易降解。考察了本品在不同ｐＨ水溶液及几种常用输液中的稳定性。A HPLC method is described for determining amoxicillin sodium (AMO) and clavulanate potassium (CLV) for injection. The method uses ODS column and borax buffer (0. 08mol/L.pH4. 0)-methoanol (95:5) as mobile phase, with UV detection at 220nm. This method is simple, rapid and accurate. The components had good linear relation and respective average recovery (n=5) (99. 90±0. 18)% for AMO and (99.76±0. 21)% for CLV. The stability of amoxicillin sodium and clavulanate potassium for injection was investigated with linear temperature program. For AMO, K25℃=2. 26×10-6/h, t0.9=3. 4 (years); for CLV. K25℃=3. 60×10-8/h, t0.9=5. 4 (years). The experiment proved that the higher its concentration is, the easier it s to degrade. Its stability in solutions of various pH and in some ordinary kinds of injections was studied also.

关 键 词：HPLC 阿莫西林钠 克拉维酸钾 稳定性 

分 类 号：R927.11[医药卫生—药学]