高效液相色谱法测定阿奇霉素干混悬剂含量.doc

高效液相色谱法测定阿奇霉素干混悬剂含量
张山,任海荣,陈娟
(石家庄欧意药业有限公司质量控制部,石家庄050051)
摘要目的:建立高效液相色谱法测定阿奇霉素干混悬剂含量。方法:采用Waters Xbridge C18柱(150mm×,5μm),·L-1 的磷酸氢二钠(pH )-乙腈(45:55)为流动相,·min-1,柱温为30℃,检测长为215nm。结果:-µg·mL-1,r =,平均回收率(n=15)%(RSD=%);本方法重复性和精密度良好(RSD<%)。结论:本方法简便、准确、重复性好,可用于阿奇霉素干混悬剂的含量测定。
关键词:阿奇霉素干混悬剂;高效液相色谱法;含量测定
Determination of azithromycin for suspension by HPLC
Zhang Shan,Ren Hairong,Chen Juan
(Quality Control of Shijiazhuang OUYI .,ltd.
Shijiazhuang050051,China)
Abstract Objective To establish a high-performance liquid chromatography(HPLC) method for quantitative determination of Azithromycin for :The column was Waters Xbridge C18(150mm×,5μm).The mobile posed of mol·L-1 Na2HP04()-acetonitrile(45:55).The flow rate was mL·min-1 , and the column temperature was 30℃.The detection wavelength was 215nm. Results: The linear relationship of azithromycin was good in the range of -µg·mL-1,The average recovery(n=15) was % and RSD(n=15) was %;RSD of repeated experiment(n=15) was %;The repeatability and precision of the method were good (RSD<%).Conclusion:This method is simple and believable with good can be effectively used for the quality control of azithromycin for suspension.
Key words:Azithromycin for suspension;HPLC;Quantitative Determina