Validación de método cromatográfico por HPLC de la valoración e identificación del (1-(1β, 16α)-21-(acetiloxi)-11-hidroxi-2´-metil-5´H-pregna-1,4-dieno[17,16-d]oxazol-3,20-diona) en Deflazacort materia prima

Validación de método cromatográfico por HPLC de la valoración e identificación del (1-(1β, 16α)-21-(acetiloxi)-11-hidroxi-2´-metil-5´H-pregna-1,4-dieno[17,16-d]oxazol-3,20-diona) en Deflazacort materia prima

Introduction. Deflazacort (DFZ) is a synthetic ozaxolinic glucocorticoid derived from prednisolone, it has anti-inflammatory properties and acts as an immunosuppressant, Deflazacort is the raw material used as the active ingredient of products marketed in pharmaceutical forms such as tablets and oral suspensions. Objective. The objective was to validate the methodology analytical by high performance liquid chromatography (HPLC), for the identification and assessment of (1-(1β,16α)-21-(acetyloxy)-11-hydroxy-2´-methyl-5´H-pregna-1,4 -dieno[17,16-d]oxazol-3,20-diona) in Deflazacort raw material under tropical climate conditions. Methodology. Using as mobile phase an isocratic mixture of methanol and water in a ratio of 80:20 with a flow of 1, 1mL/min, the column used was Luna® 5µm C8 100Ǻ 250 x 4.6mm, diode array detector at a wavelength of 245nm. Results: For linearity, a correlation coefficient R ≥ 0.999 was obtained, the coefficient of variation did not exceed the RS D of 2.0% in the repeatability of the system and in intermediate precision between analysts, an RSD value <3.0% was identified, in accuracy a recovery percentage of 98.9% was found.  Conclusions. The method is linear, precise, exact, robust for a flow of 1.21mL/min and not for a flow of 0.99mL/min since it does not meet retention time. In the performance tests, Deflazacort showed low stability when exposed to degradation by basic hydrolysis with 1.0 N and 0.1 N NaOH solutions. The sample and the standard in solution showed to be stable at room temperature for two hours and refrigerated for three hours.