摘要
目的建立注射用益气复脉(冻干)药品中氯化丁基橡胶塞用抗氧剂2,6-二叔丁基-4-甲基苯酚(BHT)和硫化剂对-特辛基苯酚的含量测定方法,并对其稳定性进行考察。方法采用ACQUITY UPLC BEH C18柱,以乙腈-0.2%甲酸水为流动相梯度洗脱,体积流量0.3 m L/min,柱温35℃,检测波长280 nm。结果 BHT和对特-辛基苯酚质量浓度在0.4~20μg/m L线性关系良好(r>0.999);准确度试验平均回收率分别为99.3%、101.9%,精密度及耐用性结果均符合要求;注射用益气复脉(冻干)稳定性考察样品中BHT和对-特辛基苯酚含量均小于限度值。结论所建立的方法准确可靠,可用于注射用益气复脉(冻干)中BHT和对-特辛基苯酚的含量测定。
Objective To establish a method for the content determination of antioxygen BHT and vulcanizing agent4-tert-octylphenol in butyl rubber plug of Yiqi Fumai Lyophilized Injection and to investigate the stability of samples. Methods The chromatographic separation was achieved on the ACQUITY UPLC BEH C18 column using acetonitrile-0.2% formic acid water as mobile phase gradient elution, the flow rate was 0.3 m L/min, column temperature was 35 ℃, and the detection wavelength was280 nm. Results Good linearity（r〉0.999）was observed in the standard curves of BHT and 4-tert-octylphenol in the range of0.4~20 μg/m L. The average recovery of BHT and 4-tert-octylphenol was 99.3% and 101.9%, respectively. The precision and durability results are in line with the requirements; the content of BHT and 4-tert-octylphenol in the study on the stability of Yiqi Fumai Lyophilized Injection sample was below the limit. Conclusion The established method was accurate and reliable and can be used for the determination of BHT and 4-tert-octylphenol in Yiqi Fumai Lyophilized injection.
作者
张艳惠
李海燕
岳洪水
鞠爱春
ZHANG Yanhui;LI Haiyan;YUE Hongshui;JU Aichun(Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300410, China;Tianjin Key Laboratory of Advanced Technology Enterprise of TCM Injections, Tianjin 300410, China)
出处
《药物评价研究》
CAS
2018年第3期496-500,共5页
Drug Evaluation Research
基金
天津市中药注射剂关键技术校企协同创新实验室建设项目(17PTSYJC00090)
天津市中药注射剂新技术企业重点实验室
