摘要
目的:建立对乙酰氨基酚注射液质量控制标准并研究其稳定性影响因素。方法:采用HPLC法即在十八烷基硅烷键合硅胶柱(250×4.6 mm,5μm),流动相0.05 mol/L醋酸铵溶液-甲醇(85:15),柱温40℃,流速1.0 mL/min,进样量10.0μL,检测波长257 nm的色谱条件下测定其所含对乙酰氨基酚的量,从检测方法的专属性、线性、回收率、精密度等方面确定检测方法的可靠性,并从光照和温度两方面考察制剂的稳定性。结果:对乙酰氨基酚注射液在62.30~186.90μg/mL线性范围内有良好的线性关系(R^(2)=0.9998),平均回收率为100.4%,建立的含量测定方法专属性强,操作简便、快速、准确、重现性好;对乙酰氨基酚注射液在常温和避光条件下储存稳定。结论:所建标准可作为该制剂的质量控制标准。
Objective:To establish the quality control standard of acetaminophen injection and to study the influencing factors of its stability.Methods:HPLC method:octadecylsilane bonded silica gel column(250×4.6 mm,5μm);mobile phase:0.05 mol/L ammonium acetate solution-methanol(85:15);column temperature:40℃;flow rate:1.0 mL/min,injection volume:10.0μL;the detection wavelength was 257 nm.The content of acetaminophen was determined under the chromatographic conditions.The reliability of the detection method was determined from the aspects of specificity,linearity,recovery rate and precision of the detection method.The stability of the preparation was investigated from the aspects of light and temperature.Results:The linear range of paracetamol injection was 62.30~186.90μg/mL(R^(2)=0.9998).The average recovery was 100.4%.The method was simple,rapid,accurate and reproducible.Acetaminophen injection was stable under normal temperature and dark conditions.Conclusion:The established standard can be used as the quality control standard of the preparation.
作者
肖昱
段锋
谢春菲
吴一峰
吴仁德
XIAO Yu;DUAN Feng;XIE Chunfei;WU Yifeng;WU Rende(Jiangxi Drug Inspection Center,Jiangxi Nanchang 330000,China)
出处
《江西化工》
2025年第1期29-32,共4页
Jiangxi Chemical Industry
基金
江西省药品监督管理局科研项目(2022GL08)。
