Calidad fisicoquímica de citrato de piperazina, materia prima realizado en un laboratorio farmacéutico nacional, 2020
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente informe tuvo como objetivo evaluar la calidad fisicoquímica de citrato de piperazina, materia prima de acuerdo a la farmacopea oficial de los Estados Unidos (USP 42). Los ensayos realizados se llevaron a cabo en el área de control de calidad de un laboratorio farmacéutico nacional, para lo cual se muestreo obteniéndose 7 muestras de citrato de piperazina, materia prima Lote: MP00021021. Los ensayos fisicoquímicos evaluados fueron: descripción; pH; solubilidad; identificación mediante espectroscopia infrarroja, cromatografía en capa delgada y citrato-reacción color; determinación de agua, pureza cromatográfica y dosaje. Se describió a la materia prima como polvo cristalino; con pH de 5.7; es soluble en agua e insoluble en alcohol y éter. En los ensayos de identificación por espectrofotometría infrarroja; el espectro I R de la preparación obtenida a partir de la muestra, presenta valores máximos solo a los mismos números de onda que el de una preparación similar del estándar de Citrato de piperazina., mientras que, en Cromatografía de Capa Delgada, la mancha principal en el cromatograma de Solución muestra 2, corresponde en valor Rf, color y tamaño a la del cromatograma de solución estándar, asimismo para el ensayo citrato- reacción color se observó un color rojo claro. En la determinación de agua señala que citrato de piperazina tiene 10.9% de agua; para la pureza cromatográfica no se detectaron etilendiamina, ni trietilendiamina. El dosaje de citrato de piperazina fue de 99.5%, calculado con respecto a la sustancia anhidra. Los resultados obtenidos fueron conformes, por lo tanto, se concluye que la materia prima Citrato de Piperazina cumple con las especificaciones de acuerdo la USP42.
Abstract The objective of this report was to evaluate the physicochemical quality of piperazine citrate, a raw material according to the official pharmacopoeia of the United States (USP 42). The tests carried out were carried out in the quality control area of a national pharmaceutical laboratory, for which sampling was obtained, obtaining 7 samples of piperazine citrate, raw material Lot: MP00021021. The physicochemical tests evaluated were: description; pH; solubility; identification by infrared spectroscopy, thin layer chromatography and citrate-color reaction; determination of water, chromatographic purity and dosage. The raw material was described as a crystalline powder; with pH of 5.7; It is soluble in water and insoluble in alcohol and ether. In the identification tests by infrared spectrophotometry; the IR spectrum of the preparation obtained from the sample, presents maximum values only at the same wavenumbers as that of a similar preparation of the Piperazine Citrate standard, while, in Thin Layer Chromatography, the main spot in the chromatogram of Sample solution 2, corresponds in Rf value, color and size to that of the standard solution chromatogram, likewise for the citrate-color reaction assay a light red color was observed. In the determination of water, it indicates that piperazine citrate has 10.9% water; for chromatographic purity neither ethylenediamine nor triethylenediamine were detected. The piperazine citrate dosage was 99.5%, calculated with respect to the anhydrous substance. The results obtained were compliant, therefore, it is concluded that the Piperazine Citrate raw material complies with the specifications according to USP42.
Abstract The objective of this report was to evaluate the physicochemical quality of piperazine citrate, a raw material according to the official pharmacopoeia of the United States (USP 42). The tests carried out were carried out in the quality control area of a national pharmaceutical laboratory, for which sampling was obtained, obtaining 7 samples of piperazine citrate, raw material Lot: MP00021021. The physicochemical tests evaluated were: description; pH; solubility; identification by infrared spectroscopy, thin layer chromatography and citrate-color reaction; determination of water, chromatographic purity and dosage. The raw material was described as a crystalline powder; with pH of 5.7; It is soluble in water and insoluble in alcohol and ether. In the identification tests by infrared spectrophotometry; the IR spectrum of the preparation obtained from the sample, presents maximum values only at the same wavenumbers as that of a similar preparation of the Piperazine Citrate standard, while, in Thin Layer Chromatography, the main spot in the chromatogram of Sample solution 2, corresponds in Rf value, color and size to that of the standard solution chromatogram, likewise for the citrate-color reaction assay a light red color was observed. In the determination of water, it indicates that piperazine citrate has 10.9% water; for chromatographic purity neither ethylenediamine nor triethylenediamine were detected. The piperazine citrate dosage was 99.5%, calculated with respect to the anhydrous substance. The results obtained were compliant, therefore, it is concluded that the Piperazine Citrate raw material complies with the specifications according to USP42.
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Keywords
citrato de piperazina, materia prima, fisicoquímico, control de calidad