Validación del método analítico mediante cuantificación espectrofotométrica UV de gemfibrozil incorporado en las microemulsiones
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Abstract
The present study aims to validate an analytical method by UV spectrophotometric for the quantification of gemfibrozil incorporated into microemulsions. Experimental development by constructing a ternary phase diagram for the identification of microemulsions. The characterization of the microemulsions was carried out by the polarized light microscopy technique. The analytical method was validated according to the parameters described by the United State Pharmacopeia (USP) 39 NF34 and International Conference on Harmonization (ICH) (2005), which evaluated linearity, robustness, intra and inter day accuracy, specificity accuracy, limits of detection and quantification. The developed method demonstrated linearity with a coefficient of determination (R2) of 0.9898, in addition to precision, accuracy and robustness for each of the tests with values that presented a coefficient of variation of less than 5 %. The results obtained were favorable, since they comply with the parameters stipulated by USP 39-NF34 (2016) and ICH (2005), indicating that the method is effective for the intended purpose.
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