HPLC-ELSD测定硫酸西索米星注射液中的主药

Determination of Sisomicin sulfate injection by HPLC-ELSD

目的建立测定硫酸西索米星含量的方法。方法采用HPLC—ELSD法，色谱柱为Waters SunFire C18柱（150mm×4．6mm，5Ixm），流动相为1．5％三氟醋酸-甲醇（95：5），流速为1．0ml·min^-1，柱温为30℃，漂移管温度为60℃，雾化气体压力为25psi。结果回归方程为：Y=1．235X＋6．156，线性范围为1．0—10．0ug（r=0．99998）；回收率为98．9％（n=9），RSD=0．86％。结论所建方法操作简便、准确、重复性好，可用于硫酸西索米星注射液的含量测定。

OBJECTIVE To establish an HPLC - ELSD method for the assay of Sisomicin sulfate injection. METHODS Chromatography was performed on a Waters SunFire C18 column（ 150 mm× 4.6 mm,5 um）at 30℃. The mobile phase composition was 1. 5% triflnoroacetic acid solution - methanol （ 95 ： 5 ） with a flow rate of 1.0 ml. min^-1. An evaporate light scattering detector （ELSD） was used as detector with gas pressure of 25 psi and drift tube temperature of 60℃. RESULTS The calibration curve was linear in the range of 1.0 - 10.0 ug, and the regressive equation was Y = 1. 235X ＋ 6. 156 （ r = 0.99998 ）. The average recovery was 99.2% （ n = 9 ） with RSD of 0.97%. CONCLUSION The method is simple, accurate, reproducible and can be used as the quality control of Sisomitin sulfate injection.