HPLC-RID法测定盐酸帕洛诺司琼注射液中甘露醇的含量测定
Determination of the Mannitol as a Excipient in Palonosetron Hydrochloride for Injection by HPLC-RID
王璐 1田甜 1曹桂红1
作者信息
- 1. 贵州省食品药品检验所,贵州 贵阳 550001
- 折叠
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,R2=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.
Abstract
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 R2 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.
关键词
盐酸帕洛诺司琼注射液/甘露醇/含量测定/高效液相-示差折光Key words
injecting Palonosetron hydrochloride/mannitol/assessing content/HPLC-RID引用本文复制引用
出版年
2024
NETL
NSTL
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