Development of ledipasvir and sofosbuvir pure certified reference materials for improving quality of pharmaceutical analysis

IF 1.8 Q3 CHEMISTRY, ANALYTICAL Journal of Chemical Metrology Pub Date : 2022-12-01 DOI:10.25135/jcm.73.2210.2591
Ibrahim F. Tahoun, M. Gab-Allah
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引用次数: 2

Abstract

: The pure materials play a pivotal role in controlling the quality of pharmaceutical products, ensuring comparability and metrological traceability of test results, and performance evaluation of measuring instruments. Herein, the purity characterization of chronic hepatitis C virus sofosbuvir and ledipasvir pharmaceuticals was established based on the assessment of mass fractions of potential impurities in the material including heavy metals, residual solvents, and water content, as well as structurally related organic impurities. The combined estimate of these impurities by mass balance approach led to indirect purity determination of sofosbuvir and ledipasvir materials. The impurities mass fractions in each material were assigned by validated chromatographic methods, Karl Fisher titrator, and inductively coupled plasma-based method. The certified purity values of sofosbuvir and ledipasvir and their corresponding expanded uncertainties (k =2.0 at 95% CL) were found (99.79±0.03) %, (99.69±0.04) %, respectively. The developed certified reference materials (CRMs) with small uncertainty values will support pharmaceutical testing laboratories in their efforts to maintain and improve the quality of results and provide them with high-order CRMs for the accurate determination of both analytes in raw materials and finished products.
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莱迪帕司韦和索非司布韦用于提高药物分析质量的纯认证对照品的研制
:纯材料在控制药品质量、确保检测结果的可比性和计量可追溯性以及测量仪器的性能评估方面发挥着关键作用。在此,基于对材料中潜在杂质(包括重金属、残留溶剂和水含量)以及结构相关有机杂质的质量分数的评估,建立了慢性丙型肝炎病毒索非布韦和莱迪帕韦药物的纯度表征。通过质量平衡法对这些杂质进行综合估计,从而间接测定了索非布韦和莱迪帕韦材料的纯度。通过经验证的色谱法、Karl Fisher滴定仪和基于电感耦合等离子体的方法分配每种材料中的杂质质量分数。索非布韦和莱迪帕韦的认证纯度值及其相应的扩展不确定度(在95%置信区间k=2.0)分别为(99.79±0.03)%和(99.69±0.04)%。所开发的具有小不确定度值的认证标准物质(CRM)将支持制药测试实验室努力维持和提高结果质量,并为他们提供高阶CRM,以准确测定原材料和成品中的分析物。
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来源期刊
Journal of Chemical Metrology
Journal of Chemical Metrology CHEMISTRY, ANALYTICAL-
CiteScore
2.30
自引率
15.40%
发文量
7
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