Determinación de atenolol 100 mg por cromatografía líquida de alta resolución en tabletas comercializadas en el Perú
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Date
2020
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Universidad Nacional de Trujillo
Abstract
La determinación del principio activo (p.a.) en un medicamento es un requisito necesario de las BPM (buenas prácticas de manufactura). Por ello el trabajo de investigación se enfocó en determinar atenolol 100 mg por cromatografía líquida de alta resolución (HPLC) en tabletas comercializadas en el Perú. Se determinó la curva de calibración para la cuantificación del p.a. de atenolol de 100 mg. Se cuantificó el p.a. por HPLC, se tomó como parámetro la linealidad. Al realizar la curva de calibración se demostró la linealidad del método dado que el coeficiente de determinación r² fue igual a 0,9998; además se determinaron las concentraciones de atenolol siendo para los medicamentos innovador (R) 101,0 mg, multifuente 1 (E1) 102,3 mg y multifuente 2 (E2) 101,2 mg. Los coeficientes de variación para R, E1 y E2 fueron 0,992%, 0,583% y 0,2840% respectivamente, los cuales fueron menores a 2%. En los cromatogramas no se observaron señales de interferencia de excipientes o productos de degradación del medicamento. Después de los análisis se concluyó que la concentración de atenolol 100 mg en tabletas de R, E1 y E2 determinadas por HPLC se encuentran entre en el rango de 90-110%, tal como lo estipula la USP.
ABSTRACT The determination of the active principle (a.p.) in a drug is a necessary requirement of the GMP (good manufacturing practices). For this reason, the research work focused on determining Atenolol 100 mg by high performance liquid chromatography (HPLC) in tablets commercialized in Peru. The calibration curve for the quantification of a.p. of Atenolol 100 mg. The a.p. by HPLC was quantified, linearity was taken as parameter. When performing the calibration curve, the linearity of the method was demonstrated, since the coefficient of determination r² was equal to 0.9998, in addition, atenolol concentrations were determined, being for the innovative (R) 101.0 mg, multi-source 1 (E1) 102.3 mg and multi-source 2 (E2) 101.2 mg drugs. The coefficients of variation for R, E1 and E2 were 0.992%, 0.583% and 0.2840% respectively, which were less than 2%. In the chromatograms no interference signals from excipients or degradation products of the drug were observed. After the analysis, it was concluded that the concentration of atenolol 100 mg in R, E1 and E2 tablets determined by HPLC is in the range of 90-110%, as stipulated by the USP.
ABSTRACT The determination of the active principle (a.p.) in a drug is a necessary requirement of the GMP (good manufacturing practices). For this reason, the research work focused on determining Atenolol 100 mg by high performance liquid chromatography (HPLC) in tablets commercialized in Peru. The calibration curve for the quantification of a.p. of Atenolol 100 mg. The a.p. by HPLC was quantified, linearity was taken as parameter. When performing the calibration curve, the linearity of the method was demonstrated, since the coefficient of determination r² was equal to 0.9998, in addition, atenolol concentrations were determined, being for the innovative (R) 101.0 mg, multi-source 1 (E1) 102.3 mg and multi-source 2 (E2) 101.2 mg drugs. The coefficients of variation for R, E1 and E2 were 0.992%, 0.583% and 0.2840% respectively, which were less than 2%. In the chromatograms no interference signals from excipients or degradation products of the drug were observed. After the analysis, it was concluded that the concentration of atenolol 100 mg in R, E1 and E2 tablets determined by HPLC is in the range of 90-110%, as stipulated by the USP.
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Keywords
atenolol, cromatografía liquida, Perú