Calidad Fisicoquímica de Clorhidrato de Olopatadina Materia Prima en un Laboratorio Farmacéutico Nacional 2022
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Date
2022
Journal Title
Journal ISSN
Volume Title
Publisher
Universidad Nacional de Trujillo
Abstract
El propósito de este informe de prácticas fue evaluar la calidad fisicoquímica de Clorhidrato de Olopatadina, materia prima, de acuerdo a la Farmacopea de los Estados Unidos (USP-NF 2021). Por lo que se realizaron diversas pruebas en control de calidad en un Laboratorio Farmacéutico Nacional. Se empezó muestreando 27,0 g de Clorhidrato de Olopatadina de lote OH0040122. Las pruebas fisicoquímicas evaluadas fueron: descripción, solubilidad, identificación, pH, pérdida por secado, residuo de incineración, impurezas orgánicas y valoración. La materia prima fue un polvo cristalino blanco. Siendo moderadamente soluble en agua y muy poco soluble en alcohol deshidratado; el espectro de absorción IR de la muestra presenta un máximo al mismo número de onda que la sustancia de referencia. En la High Performance Liquid Cromatography, el tiempo que corresponde al pico principal retenido fue 13,12 minutos, cuando se identifica cloruros se observó la formación de un precipitado grumoso blanco, cuando se agrega ácido nítrico no disolvía, sin embargo, se disolvió en superabundancia de amonio hidróxido 6N. El pH fue igual a 2,8; la pérdida por secado fue de 0,10%. El valor de residuo de incineración fue de 0,04%; no presenta impurezas orgánicas, en la valoración se obtuvo un 100,6% en base a la sustancia seca. Se concluyó que Clorhidrato de Olopatadina, materia prima cumple con lo establecido en la USP-NF 2021.
ABSTRACT The purpose of this practice report was to evaluate the physicochemical quality of Olopatadine Hydrochloride, raw material, according to the United States Pharmacopeia (USP-NF 2021). Therefore, various quality control tests were carried out in a National Pharmaceutical Laboratory. It began by sampling 27.0 g of Olopatadine Hydrochloride from lot OH0040122. The physicochemical tests evaluated were: description, solubility, identification, pH, loss on drying, incineration residue, organic impurities and assessment. The raw material was a white crystalline powder. Being moderately soluble in water and very slightly soluble in dehydrated alcohol; the IR absorption spectrum of the sample shows a maximum at the same wavenumber as the reference standard. In High Performance Liquid Chromatography (HPLC), the retention time of the main peak was 13.12 minutes, according to the titration; in the identification of chlorides, the formation of a lumpy white precipitate was observed that did not dissolve when adding nitric acid, however, it dissolved in an excess of 6N ammonium hydroxide. In the pH, a value of 2.8 was obtained; in the loss on drying a value of 0.10% was obtained. The value obtained for the incineration residue was 0.04%; it does not present organic impurities and finally in the titration a value of 100.6% calculated with respect to the dry substance was obtained. It was concluded that Olopatadine Hydrochloride, raw material, complied with the specifications according to USP-NF 2021.
ABSTRACT The purpose of this practice report was to evaluate the physicochemical quality of Olopatadine Hydrochloride, raw material, according to the United States Pharmacopeia (USP-NF 2021). Therefore, various quality control tests were carried out in a National Pharmaceutical Laboratory. It began by sampling 27.0 g of Olopatadine Hydrochloride from lot OH0040122. The physicochemical tests evaluated were: description, solubility, identification, pH, loss on drying, incineration residue, organic impurities and assessment. The raw material was a white crystalline powder. Being moderately soluble in water and very slightly soluble in dehydrated alcohol; the IR absorption spectrum of the sample shows a maximum at the same wavenumber as the reference standard. In High Performance Liquid Chromatography (HPLC), the retention time of the main peak was 13.12 minutes, according to the titration; in the identification of chlorides, the formation of a lumpy white precipitate was observed that did not dissolve when adding nitric acid, however, it dissolved in an excess of 6N ammonium hydroxide. In the pH, a value of 2.8 was obtained; in the loss on drying a value of 0.10% was obtained. The value obtained for the incineration residue was 0.04%; it does not present organic impurities and finally in the titration a value of 100.6% calculated with respect to the dry substance was obtained. It was concluded that Olopatadine Hydrochloride, raw material, complied with the specifications according to USP-NF 2021.
Description
Keywords
Clorhidrato de olopatadina, Control de calidad, Materia prima, Calidad
fisicoquímica.