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Validacion de fases estacionarias en la cromatografía planar de 111In-pentetreotida


, : Validacion de fases estacionarias en la cromatografía planar de 111In-pentetreotida.

Tras el cese en la fabricaci n de ITLC-SG por Pall-Gelman, es necesaria la validaci n de fases estacionarias alternativas. Validar diferentes fases estacionarias frente a ITLC-SG de Pall-Gelman en la determinaci n de la pureza radioqu mica (PRQ) de 111In-pentetre tida (111In-Octreoscan) por cromatograf a planar. Realizamos un estudio caso-control en el que incluimos 66 preparaciones de 111In-pentetre tida. Determinamos la PRQ mediante cromatograf a plana, empleando una soluci n reci n preparada de citrato de sodio de 0,1M (pH 5) y las siguientes fases estacionarias: ITLC-SG (Pall-Gelman) (m todo de referencia), iTLC-SG (Varian), Silicagel 60 HPTLC (Merck), Whatman 1, Whatman 3MM y Whatman 17. Para cada uno de los m todos calculamos: PRQ, factores de retenci n (RF) del radiof rmaco e 111In libre, tiempo de desarrollo cromatogr fico y resoluci n entre picos. Comparamos los resultados obtenidos con los del m todo de referencia. Para el an lisis estad stico de datos utilizamos el programa SPSS. Para el estudio de significaci n estad stica calculamos el valor de p. Con Silicagel 60 HPTLC (Merck) se obtiene la mayor resoluci n, aunque el tiempo de desarrollo cromatogr fico es prolongado (media=33,62min). Con iTLC-SG (Varian) se obtiene una resoluci n mayor que con el m todo de referencia, siendo menor el tiempo de desarrollo cromatogr fico (media=3,61min). Con papel Whatman se obtienen resoluciones muy bajas, fundamentalmente con Whatman 1 y 3MM, por lo que no recomendamos su utilizaci n. Aunque iTLC-SG (Varian) y Silicagel 60 HPTLC (Merck) son alternativas adecuadas a ITLC-SG (Pall-Gelman) en la determinaci n de la PRQ de 111In-pentetre tida, iTLC-SG (Varian) es el m todo de elecci n por su menor tiempo de desarrollo cromatogr fico. Since Pall-German stopped manufacturing ITLC-SG, it has become necessary to validate alternative stationary phases. To validate different stationary phases versus ITLC-SG Pall-Gelman in the determination of the radiochemical purity (RCP) of 111In-pentetreotide (111In-Octreoscan) by planar chromatography. We conducted a case-control study, which included 66 111In-pentetreotide preparations. We determined the RCP by planar chromatography, using a freshly prepared solution of 0,1M sodium citrate (pH 5) and the following stationary phases: ITLC-SG (Pall-Gelman) (reference method), iTLC-SG (Varian), HPTLC silica gel 60 (Merck), Whatman 1, Whatman 3MM and Whatman 17. For each of the methods, we calculated: PRQ, relative front values (RF) of the radiopharmaceutical and free 111In, chromatographic development time, resolution between peaks. We compared the results obtained with the reference method. The statistical analysis was performed using the SPSS program. The p value was calculated for the study of statistical significance. The highest resolution is obtained with HPTLC silica gel 60 (Merck). However, the chromatographic development time is too long (mean=33.62minutes). Greater resolution is obtained with iTLC-SG (Varian) than with the reference method, with lower chromatographic development time (mean=3.61minutes). Very low resolutions are obtained with Whatman paper, essentially with Whatman 1 and 3MM. Therefore, we do not recommend their use. Although iTLC-SG (Varian) and HPTLC silica gel 60 (Merck) are suitable alternatives to ITLC-SG (Pall-Gelman) in determining the RCP of 111In-pentetreotide, iTLC-SG (Varian) is the method of choice due to its lower chromatographic development time.

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