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一种用于在微藻生物修复过程中同时分析对乙酰氨基酚、布洛芬、奥氮平和辛伐他汀的反相高效液相色谱法的开发与验证

Development and validation of a RP-HPLC method for the simultaneous analysis of paracetamol, ibuprofen, olanzapine, and simvastatin during microalgae bioremediation.

作者信息

Encarnação Telma, Aguiar António, Palito Cátia, Pais Alberto A C C, Campos Maria G, Sobral Abílio J F N, Burrows Hugh D

机构信息

CQC, Department of Chemistry, University of Coimbra, 3004-535 Coimbra, Portugal.

出版信息

MethodsX. 2020 Sep 28;7:101083. doi: 10.1016/j.mex.2020.101083. eCollection 2020.

Abstract

A rapid reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous quantification of paracetamol, ibuprofen, olanzapine, simvastatin and simvastatin acid in the context of microalgae bioremediation. The method was validated according to the guidelines of the US Food and Drug Administration (FDA), the International Conference on Harmonization (ICH), and Eurachem with respect to system suitability, linearity, accuracy, precision, recovery, limits of detection and quantification, ruggedness, selectivity and specificity. The estimated limits of detection and quantification were, respectively, 0.03 and 0.10 µg mL for paracetamol, 0.03 and 0.09 µg mL for ibuprofen, 0.04 and 0.13 µg mL for olanzapine, 0.27 and 0.83 µg mL for simvastantin, and 0.05 and 0.14 µg mL for simvastantin acid. The inter-day and intra-day precision results were within the acceptance limit of relative standard deviation (%RSD) of less than 2, and the percentage recovery was found to be within the required limits of 80-110%. The developed method is rapid, linear, precise, robust and accurate, and has been successfully applied to the determination of the above common pharmaceutical products during microalgae bioremediation.

摘要

建立了一种快速反相高效液相色谱(RP-HPLC)方法,并对其进行了验证,用于在微藻生物修复背景下同时定量对乙酰氨基酚、布洛芬、奥氮平、辛伐他汀和辛伐他汀酸。该方法根据美国食品药品监督管理局(FDA)、国际协调会议(ICH)和欧洲化学会的指导方针,在系统适用性、线性、准确性、精密度、回收率、检测限和定量限、耐用性、选择性和特异性方面进行了验证。对乙酰氨基酚的估计检测限和定量限分别为0.03和0.10μg/mL,布洛芬为0.03和0.09μg/mL,奥氮平为0.04和0.13μg/mL,辛伐他汀为0.27和0.83μg/mL,辛伐他汀酸为0.05和0.14μg/mL。日间和日内精密度结果在相对标准偏差(%RSD)小于2的可接受范围内,回收率百分比在80-110%的要求范围内。所建立的方法快速、线性、精确、稳健且准确,并已成功应用于微藻生物修复过程中上述常见药品的测定。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd37/7569217/1927cd19838a/fx1.jpg

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