Browsing by Author "Osorio Pelayo, Juan David"
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Item Validación de una metodología analítica para la valoración de la materia prima Deflazacort (DFZ) e identificación de su Impureza 21-Desacetil Deflazacort, con estudio cinético de degradación de DFZ por HPLC(Universidad Santiago de Cali, 2024) Osorio Pelayo, Juan David; Chamorro Rengifo, Andrés Felipe (Director); Lara Mercado, Eder José (Director)The production of drugs requires a rigorous guarantee of the drug concentration and the precise identification of its impurities. This research validates the analytical methodology for the titration of the active pharmaceutical ingredient (API) deflazacort, a raw material used in the formulation of tablets and oral suspensions for the treatment of Duchenne Muscular Dystrophy (DMD). The main objective of this work was to validate a high-performance liquid chromatography (HPLC) method to quantify Deflazacort and identify its impurity, 21-Desacetyl Deflazacort, as well as to evaluate the degradation kinetics of PFA under various physicochemical conditions. The methodology employed included the use of a photodiode array detector (DMF) at a wavelength of 254 nm, and a Luna C18 column (250 mm x 4,6 mm x 5 µm). The results showed linearity with a correlation coefficient R2 = 0,999. The precision of the system showed a coefficient of variation of less than 2,0 % RSD, and in the intermediate precision between analysts a % RSD of 0,7 % was obtained. The accuracy yielded a recovery rate of 100,1 %. The method is selective and precise, a degradation with acid hydrolysis of 8,1 % was evidenced, with H2O2, 2,1 %, with ultraviolet light 1,8 % and thermolysis 1,8 %, but only in basic conditions. Regarding the degradation kinetics of PFA Deflazacort, it was observed that the basic hydrolysis follows a first order kinetics with 97,1 % degradation, generating the impurity 21-Desacetyl Deflazacort, this degradation product was successfully identified by comparing absorption spectra at a wavelength of 245 nm with the USP standard impurity 21-Desacetyl Deflazacort. In conclusion, the validated analytical methodology is linear, precise, accurate and robust, complying with the parameters established by the USP.