Desarrollo de un método analítico por cromatografía líquida de alta eficacia para la cuantificación de etinilestradiol y desogestrel comprimidos
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Date
2021
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Universidad Nacional de Trujillo
Abstract
El presente informe tuvo como objetivo principal, desarrollar un método analítico por cromatografía líquida de alta eficacia para la cuantificación de etinilestradiol y desogestrel comprimidos. El desarrollo de la metodología se hizo en un equipo HPLC Thermo Scientific™ UltiMate™ 3000 UHPLC y la separación cromatográfica se logró en una columna BDS Hypersil C18 150 mm x 4,6 mm y 5 µm. El método de tipo en elución gradiente emplea 2 soluciones A y B como fase móvil, la solución A esta compuesta por agua purificada y acetonitrilo (90:10) y la solución B contiene una mezcla de agua purificada y acetonitrilo (5:95). La velocidad de flujo fue de 1,0 mL/min y la longitud de onda de detección fue de 208 nm; con un tiempo de retención de 3,092 y 8,958 para etinilestradiol y desogestrel respectivamente. El método desarrollado fue lineal obteniéndose un coeficiente de determinación (𝑅2) mayor de 0,99 para etinilestradiol y desogestrel respectivamente. Los límites de detección y cuantificación para etinilestradiol fueron 0,42 μg/mL e 1,29 μg/mL respectivamente y para desogestrel 3,29 μg/mL e 9,99 μg/mL correspondientemente. Además, demostró ser específico para la determinación de ambos ingredientes principios farmacéuticos activos. El método desarrollado probó ser adecuado para la cuantificación de etinilestradiol y desogestrel comprimidos, previa validación respectiva
ABSTRACT The main objective of this report was to develop a high performance liquid chromatographic analytical method for the quantification of ethinyl estradiol and desogestrel tablets. The development of the methodology was done on a Thermo Scientific ™ UltiMate ™ 3000 UHPLC HPLC equipment and the chromatographic separation was achieved on a BDS Hypersil C18 150 mm x 4,6 mm and 5 µm column. The gradient elution type method uses 2 solutions A and B as mobile phase, solution A is composed of purified water and acetonitrile (90:10) and solution B contains a mixture of purified water and acetonitrile (5:95). The flow rate was 1.0 mL / min and the detection wavelength was 208 nm; with a retention time of 3,092 and 8,958 for ethinylestradiol and desogestrel respectively. The method developed was linear, obtaining a coefficient of determination (R ^ 2) greater than 0,99 for ethinyl estradiol and desogestrel, respectively. The detection and quantification limits for ethinylestradiol were 0,42 μg / mL and 1,29 μg / mL respectively and for desogestrel 3,29 μg / mL and 9,99 μg / mL correspondingly. Furthermore, it proved to be specific for the determination of both active pharmaceutical ingredients. The developed method proved to be suitable for the quantification of ethinylestradiol and desogestrel tablets, after the respective validation
ABSTRACT The main objective of this report was to develop a high performance liquid chromatographic analytical method for the quantification of ethinyl estradiol and desogestrel tablets. The development of the methodology was done on a Thermo Scientific ™ UltiMate ™ 3000 UHPLC HPLC equipment and the chromatographic separation was achieved on a BDS Hypersil C18 150 mm x 4,6 mm and 5 µm column. The gradient elution type method uses 2 solutions A and B as mobile phase, solution A is composed of purified water and acetonitrile (90:10) and solution B contains a mixture of purified water and acetonitrile (5:95). The flow rate was 1.0 mL / min and the detection wavelength was 208 nm; with a retention time of 3,092 and 8,958 for ethinylestradiol and desogestrel respectively. The method developed was linear, obtaining a coefficient of determination (R ^ 2) greater than 0,99 for ethinyl estradiol and desogestrel, respectively. The detection and quantification limits for ethinylestradiol were 0,42 μg / mL and 1,29 μg / mL respectively and for desogestrel 3,29 μg / mL and 9,99 μg / mL correspondingly. Furthermore, it proved to be specific for the determination of both active pharmaceutical ingredients. The developed method proved to be suitable for the quantification of ethinylestradiol and desogestrel tablets, after the respective validation
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Keywords
Cromatografía de Alta Eficacia. Etinilestradiol. Desogestrel