Abstract

CORDOVI-VELAZQUEZ, Juan Manuel et al. Chromatographical method for the simultaneous determination of acetaminophen, metilparaben and propilparaben in Paracetamol Oral Solution. Rev Cub Quim [online]. 2023, vol.35, n.1, pp. 141-166.  Epub Jan 17, 2023. ISSN 2224-5421.

This work has been intended for the exhaustive validation of the method for HPLC in reverse phase for the quantification of acetaminophen, methylparaben and propylparaben in formulations of Paracetamol Oral Solution 120 mg/5 mL, of the Medilip Pharmaceutical Laboratory from Bayamo. The following parameters in the process of validation were evaluated: system suitable test, selectivity, linearity, precision, accuracy, interval of work, robustness, limits of detection and quantification. The methodologies followed according to Resolution 40/2014 of the Center for the State Control of the Quality of the Medicaments and Medical Devices as well as, the Norm Cuban NC TS 368:2010, Guide for the validation of methods of chemical assay. The proposed method was selective, linear, robust, accurate and precise for the interval of 80 to 120 %. These results demonstrate that the method for the quantification of the acetaminophen and parabens in the quality control of the finished product can be utilized.

Keywords : acetaminophen; parabens; chromatography; validation..

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