التفاصيل البيبلوغرافية
| العنوان: |
Validation of a limit test for the analysis of loratadine in a syrup for pediatric use ; Validación de una prueba límite para análisis de loratadina en un jarabe para uso pediátrico |
| المؤلفون: |
Sagastume, Reyna M., Suárez, Yania |
| المصدر: |
Revista de Ciencias Farmaceúticas y Alimentarias; Vol. 5 No. 2 (2019): First content issue of 2019 ; Revista de Ciencias Farmacéuticas y Alimentarias; Vol. 5 Núm. 2 (2019): Primer número de contenido del 2019 ; 2411-927X |
| بيانات النشر: |
Instituto de Farmacia y Alimentos Universidad de La Habana |
| سنة النشر: |
2023 |
| مصطلحات موضوعية: |
loratadina, cromatografía en capa delgada, prueba límite, validación, loratadine, thin layer cromathographic, limit test, validation |
| الوصف: |
It was developed and validated as limit test, a simple and fast method through thin layer chromatography for his application to the follow up of the chemical stability of the loratadine present on a syrup in development stage for children usage. As support were used chromatographic plates of silica gel G 60 F 254, 10 L of sample and physical reveled under UV light at 254 nm. Three possible dissolvent systems were evaluated, selecting the combination B: N-butyl acetate, carbon tetrachloride, acetic acid, acetonitrile 3: 6: 0.2: 3 (v/v) as the one with better results in presence of the formulation excipients, capable of detecting differences between the intensity of the principal spots between 90 and 100 percent concentration. Posteriorly, was evaluated the specificity of the selected method against the possible degradation products generated on forced conditions. Additional spots were detected, attributable to degradation on basic mean of loratadine and the effect of exposure to natural light for seven days. Neither the loratadine nor the excipients degraded on the remaining tested conditions. 1 g of limit of detection in a reproducible form was obtained among the three experimental samples. The possible influence of temperature and light in physical and chemical stability of the developed formulation was evaluated, once conditioned on the primary container (amber glass flask with polypropylene lid) through a pre-stability study on syrup samples of three batches elaborated at laboratory scale (L001, L002 and L003), during a 60 days’ period. The temperature didn’t significantly affect the studied syrup at short term. The used container functioned as a protection barrier from the incidence of natural light. ; Se desarrolló y validó como prueba límite, un método simple y rápido por cromatografía en capa delgada para su aplicación al seguimiento de la estabilidad química de la loratadina presente en un jarabe para uso pediátrico en fase de desarrollo. Se utilizaron como soportes placas recubiertas con sílica gel G ... |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
Spanish; Castilian |
| العلاقة: |
https://revistas.uh.cu/rcfa/article/view/3667/3215Test; https://revistas.uh.cu/rcfa/article/view/3667Test |
| الإتاحة: |
https://revistas.uh.cu/rcfa/article/view/3667Test |
| حقوق: |
Derechos de autor 2023 Reyna M. Sagastume, Yania Suárez ; https://creativecommons.org/licenses/by-nc/4.0Test |
| رقم الانضمام: |
edsbas.202ECD5C |
| قاعدة البيانات: |
BASE |
