HPLC法测定注射用替加环素含量及有关物质

Determination of tigecycline for injection with HPLC

目的建立注射用替加环素含量测定及有关物质检查法。方法采用Phenomenex Gemini C18柱，0．1mol·L-1磷酸氢二铵溶液-三乙胺-甲醇（50：1：49）[用磷酸调节pH值至6．3]为流动相，流速1．0ml·min-1，柱温30℃，检测波长248nm。结果替加环素在1．07—3．21μg范围内，线性关系良好（r=0．9999），平均回收率99．60％，RSD为0．9％。结论方法可用于替加环素含量测定及有关物质，方法简便，结果准确可靠。

Aim To develop an RP-HPLC method for determination of tigeeycline and its related substances. Methods The column was Phenomenex Gemini C ls （250 mm× 4.6 mm ,5 μm）. The mobile phase was 0.1 mol ·L-1 ammonium phosphate dibasic-triethylamine- methanol （50：1：49 ）（ pH adjusted to 6.3 ）. The flow rate was 1.0 ml· min-1, with a wavelength of 248 nm at a temperature of 30℃. Results Over the range from 1.07 to 3.21 μg, the linearity was satisfying（ r = 0. 999 9）. The average recovery rate was 99.60% （ RSD = 0.9% ）. Conclution The method was reliable and accurate for determination of tigecycline and its related substances for injection.