摘要
目的建立硫酸妥布霉素氯化钠注射液含量测定的HPLC-ELSD法。方法采用HPLC-ELSD法测定了硫酸妥布霉素氯化钠注射液的含量。色谱条件:Waters Sunfire C18色谱柱,1.5%三氟醋酸-甲醇(97∶3)为流动相,流速0.5mL·min-1。柱温30℃。ELSD检测器:漂移管温度为60℃,雾化气体压力为25psi。结果妥布霉素在2.4～38.4μg的范围内,线性关系良好,r=0.9998。平均回收率为99.2%(n=9),RSD为0.97%;氯化钠在20～200μg的范围内,线性关系良好,r=0.9999。平均回收率为99.0%(n=9),RSD为0.89%。结论该方法操作简便、准确、重复性好,可用于该制剂的含量测定。
Objective To establish an HPLC-ELSD method for assay of Tobramycin Sulfate and Sodium Chloride Injection. Methods Chromatography was performed on an Waters surfire C18 column. The mobile phase composition was 1.5% trifluoroacetic acid solution-methanol （97：3） with a flow rate of 0. 5mL·min^-1. An evaporate light scattering detector （ELSD） was used as detector with gas press of 25 psi and drift tube temperature of 60℃ Results The calibration curve of tobramycin was linear in the range 2.4 -38.4μg. The average recovery was 99.2% （n=9）, RSD was 0. 97%. The calibration curve of sodium chloride was linear in the range 20-200μg. The average recovery was 99.0% （n=9）, RSD was 0. 89%. Conclusions The method is simple, accurate and reproducible. It can be used as a quality control of Tobramycin Sulfate and Sodium Chloride Injection.
出处
《中国药事》
CAS
2009年第5期461-463,共3页
Chinese Pharmaceutical Affairs
