Estudio comparativo de las ventajas de la HPLC en relación con la Fluorometría en la determinación de vitaminas B1 y B2 en jarabes infantiles.
Fecha
2004
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Universidad de Guayaquil. Facultad de Ciencias Químicas
Resumen
Con la finalidad de controlar la calidad de los medicamentos en este caso jarabes infantiles se efectuó un estudio comparativo para la determinación de vitaminas B1 y B2 por Cromatografía Líquida de Alta Eficiencia (HPLC) y por Espectrofotometría utilizando un Fluorómetro.
Para la precisión y adecuación del sistema se evaluaron tres parámetros: Coeficiente de variación, Tailing y número de platos teóricos para el caso del HPLC y el Coeficiente de Variación para el fluorómetro, obteniéndose para el HPLC un Coeficiente de Variación de 0.1 %, un Tailing de 1.41 y 0.99 para la vitamina B1 y B2 respectivamente, para el caso del Fluorómetro se obtuvo un Coeficiente de Variación de 1.77 para la vitamina B1 y 0.65 para la vitamina B2, en la Linealidad se obtuvo un Coeficiente de correlación de 0.99 para ambas vitaminas para el caso del HPLC y para el Fluorómetro de 0.98 para la vitamina B1 y de 0.99 para la vitamina B2.
La exactitud del método se evaluó en términos de recuperación mediante la adición de cantidades conocidas de vitaminas, obteniéndose un porcentaje de recuperación de 99.20 % para el HPLC y de 97.04 % para el Fluorómetro.
La especificidad se la obtuvo mediante la lectura de un placebo en la cual solo el HPLC no presento interferencia del principio activo con los excipientes.
Con los resultados obtenidos se demuestra que el método cromatográfico es preciso, específico, consistente y exacto en la determinación de vitaminas B1 y B2 en jarabes infantiles que la aportada por el fluorómetro.
With the purpose of controlling the drug’s quality, in this case children syrups, a comparative study was made to determinate vitamins B1 and B2 by High Performance Liquid Chromatography (HPLC) and Spectrophotometry using a fluorometer. For the precision and adaptation of the system, three parameters were evaluated: The coefficient of variation, Tailing and number of USP Plate count; for bath we gat for the HPLC a coefficient of variation of 0.1%, a tailing of 1.41 and 0.99 for the vitamin B1 and B2 respectively, in the case of the fluorometer we obtained a coefficient of variation of 1.77 in the vitamin B1 and 0.65 in the vitamin B2; in the lineality a correlative coefficient for both vitamins was 0.99, in the case of HPLC and for the fluorometer the correlative coefficient was 0.98 for the vitamin B1 and 0.99 for the vitamin B2. The accuracy of the method was evaluated in recovery terms trough of the addition of well-known quantities of vitamins, we obtained for HPLC 99.20% of recovery and 97.04% for the fluorometer. The specificity that we obtained by means of the reading of a placeb in which only the HPLC did not show interference of the active with the exicipients. With the obtained results we can show that the Chromatographic method is necessary, specific, consistent and exact in the determination of vitamin B1 and B2 in children syrups than the one contributed by the fluorometer.
With the purpose of controlling the drug’s quality, in this case children syrups, a comparative study was made to determinate vitamins B1 and B2 by High Performance Liquid Chromatography (HPLC) and Spectrophotometry using a fluorometer. For the precision and adaptation of the system, three parameters were evaluated: The coefficient of variation, Tailing and number of USP Plate count; for bath we gat for the HPLC a coefficient of variation of 0.1%, a tailing of 1.41 and 0.99 for the vitamin B1 and B2 respectively, in the case of the fluorometer we obtained a coefficient of variation of 1.77 in the vitamin B1 and 0.65 in the vitamin B2; in the lineality a correlative coefficient for both vitamins was 0.99, in the case of HPLC and for the fluorometer the correlative coefficient was 0.98 for the vitamin B1 and 0.99 for the vitamin B2. The accuracy of the method was evaluated in recovery terms trough of the addition of well-known quantities of vitamins, we obtained for HPLC 99.20% of recovery and 97.04% for the fluorometer. The specificity that we obtained by means of the reading of a placeb in which only the HPLC did not show interference of the active with the exicipients. With the obtained results we can show that the Chromatographic method is necessary, specific, consistent and exact in the determination of vitamin B1 and B2 in children syrups than the one contributed by the fluorometer.
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HPLC, VITAMINA, FLUOROMETRIA