高效液相色谱法测定注射用乳糖酸红霉素含量

Determination of Erythromycin Lactobionate for injection by HPLC

目的 建立高效液相色谱法测定注射用乳糖酸红霉素中乳糖酸红霉素的含量.方法 以Hyersil BDS C18（4.6×250mm,5μm）为色谱柱;以0.05mol·L-1磷酸二氢铵（三乙胺调pH至6.0）-乙腈（60：40）为流动相;流速为1.0mL·min-1;检测波长为210nm;柱温25℃.结果 乳糖酸红霉素与其他有关物质分离度良好,在进样量25～150μg的范围内与峰面积线性关系良好（r=0.9999）;平均回收率为99.66%,RSD为1.28%（n=9）,辅料对检测无影响.与效价法比较,两者方法无显著性差异.结论 本方法快捷简便,结果准确,重现性好,可用于乳糖酸红霉素含量测定.

OBJECTIVE To establish a HPLC method for the determination of Erythromycin lactobionate for injection. METHODS The chromatographic condition included Hypersil BDS C18 （4. 6 × 250mm,5 μm） ;the mobile phase was composed of 0. 05mol·L-1 ammonium dihydrogen phosphate （adjustd with triethylamine pH to 6. 0） and acetonitrile （60：40）. The flow rate was 1mL·min-1. The detection was 210nm. column temperature was 25℃. RESULTS Erythromycin lactobionate was separated well other relevant material. There was a good linear relation- ship between erythromycin lactobionate and peak area when the sample inject was from 25- 150μg（ r = 0. 9999） ;the average recovery rate was 100.06% and RSD was 1.28% （ n = 9 ）, accessories to detect was without influenee. Compared with titer method, both methods were no significant differences. CONCLUSION The method is simple and believable,it can be effectively used for the quality control of erythromycin lactobionate injection.