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

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作者:Encarnação Telma, Aguiar António, Palito Cátia, Pais Alberto A C C, Campos Maria G, Sobral Abílio J F N, Burrows Hugh D
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(-1) for paracetamol, 0.03 and 0.09 µg mL(-1) for ibuprofen, 0.04 and 0.13 µg mL(-1) for olanzapine, 0.27 and 0.83 µg mL(-1) for simvastantin, and 0.05 and 0.14 µg mL(-1) 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.

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