HPLC法测定注射用阿奇霉素的含量

摘要

Objective To establish a method for determination of azithromycin for injection by HPLC.Methods Inertsil ODS-SP(4.6 mm ×250 mm,5 μm)C18 column was used with 0.1 mol·L-1 ammonium acetate solution(the ammonia solution adjusted to pH 8.6)-acetonitrile-methanol(50∶30∶20)as mobile phase.The flow rate was set at 1.0 mL·min-1.The wavelength used for detection was 218 nm.The column temperature was 60℃.Results The linear range was 100~2 000 mg·L-1 (r=0.999 8).The average recovery(n=9)was 98.8%(RSD=0.6%).Conclusions The method is rapid,simple and accurate.%目的：建立反相高效液相法测定注射用阿奇霉素含量的方法。方法采用Inertsil ODS柱（4．6 mm ×250 mm，5μm），以0．1 mol·L－1乙酸铵（用氨水调节pH值至8．6）—乙腈—甲醇（50∶30∶20）为流动相，流速1．0 mL·min－1，检测波长218 nm，柱温60℃。结果阿奇霉素的线性范围为100～2000 mg·L－1，r＝0．9998，平均回收率98．8％，RSD＝0．6％（n＝9）。结论该方法简便快速、准确，更适于控制注射用阿奇霉素的质量。