摘要
目的:建立高效液相色谱-示差折光检测法(HPLC-RID)来测定盐酸帕洛诺司琼注射液中辅料甘露醇的含量。方法:使用Carbomix Ca-NP作为填充剂的色谱柱,流动相是纯化水,流速0.5 mL/min,T_(柱温)=80℃,T_(检测)=50℃。结果:得出线性回归公式为y=5.9966X+0.0909,R^(2)=0.9997。研究结果揭示,甘露醇在2.42382~5.65558 mg/mL的浓度范围内展现出很好的线性关系,其精密度RSD达到0.67%;而重复性的平均含量为41.2308 mg/mL,在6个供试品中,其含量的RSD为0.42%;平均回收率为99.69%,其RSD为0.58%(n=9)。定量限和检出限为323.176 ng和121.1911 ng。6个批次的样品含量测定分别为41.176,41.3023,41.4692,41.5302,41.1616,41.2308(mg/mL),RSD=0.38%。结论总结来说,这种方法具有很高的专一性和精密度稳定性,准确性也相当高,因此可以作为测定盐酸帕洛诺司琼注射液中甘露醇含量的有效手段。
To develop an HPLC-RID technique for measuring mannitol levels in palosetron hydrochloride injections.The technique employed was High-performance liquid chromatography using a robust cation calcium exchange column containing Carbomix Ca-NP,with water serving as the mobile phase,a flow rate of 0.5 mL/min,a column temperature of 80℃,and a detection temperature of 50℃.Findings:the formula for linear regression stood at y=5.9966x+0.0909,with an R^(2) value of 0.9997.Findings indicated a strong linear correlation between mannitol and the range of 2.42382 mg/mL to 5.65558 mg/mL,with a precision RSD of 0.67%,a repeatability average of 41.2308 mg/mL,and a 0.42%RSD for six samples,and an average recovery rate of 99.69%with a 0.58%RSD(N=9).Quantification and detection thresholds stood at 323.176 ng and 121.1911 ng in that order.Across six separate batches,the recorded values were 41.176,41.3023,41.4692,41.5302,41.1616,41.2308(mg/mL),with an RSD of 0.38%.Conclusion:The technique is precise,reliable,and precise,suitable for measuring mannitol in palosetron hydrochloride injections.
作者
王璐
田甜
曹桂红
Wang Lu;Tian Tian;Cao Guihong(Institute for Food and Drug Control in Guizhou,Guiyang 550001,China)
出处
《广东化工》
CAS
2024年第12期160-162,共3页
Guangdong Chemical Industry
基金
2015年国家药品标准提高项目(271)。
