对中国药典诺氟沙星对照品在不同溶媒中的稳定性研究

Study on the stability of Norfloxacin referent in different solvents

目的 考察不同溶媒配制的诺氟沙星对照品溶液能否保存。方法 用紫外分光光度法分别对 5℃放置的使用不同溶媒的对照品溶液在 0d、10d、2 0d、30d、4 0d测定最大吸收波长、吸收值。结果 以 0 4 %NaOH溶液为溶媒的诺氟沙星对照液于 5℃放置 4 0d ,最大吸收波长、吸收值均未发生变化 (无显著性差异P >0 0 5 )。而以pH4 0醋酸缓冲液、pH7 4磷酸盐缓冲液为溶媒的两对照液于 5℃放置 4 0d ,最大吸收波长未发生变化 ,但吸收值明显降低 (有显著性差异P <0 0 5 )。结论 用 0 4 %NaOH溶液配制的诺氟沙星对照品溶液在适宜的条件下 (5℃ ,避光密闭 )保存 ,4 0d内是稳定的 ,可继续使用。而用pH4 0醋酸缓冲液和 pH7 4磷酸盐缓冲液配制的诺氟沙星对照品溶液则不能保存使用 ,必须临用新配。

Objective To study the stability of Norfloxacin referent in different solvent Method The solutions were preserved under 5℃ At the 10th,20th,30th and40th day,we determind the λ max and the absorbance of them with UV VIS spectrophotometry Results The Norfloxacin referent was steady in the NaOH solution(0 4%) Its λ max and absorbance didn't change In the HAc solution(pH4 0) and in the phospHate solution(pH7 4) their λ max did not change but the absorbance reduced obviously Conclusion Under 5℃,the Norfloxacin referent is steady in the NaOH solution(0 4%) It could be used normally in 40 day In the HAc solution(pH4 0) and in the phosphate solution(pH7 4),the Norfloxacin referent is not steady They should be fresh when we use them