info:eu-repo/semantics/bachelorThesis
Equivalencia de la uniformidad de contenido de tres lotes de tabletas de piridoxina clorhidrato 50 mg”
Fecha
2010Autor
Briceño Boñón, Julia Marianela
Institución
Resumen
The study was conducted in order to compare the equivalence of the Content Uniformity of three lots of tablets 50 mg pyridoxine hydrochloride, and thus know if the product is within specifications set by the USP XXXII. Samples were taken randomly and were identified by lot number was used 100 tablets of pyridoxine hydrochloride 50 mg from each batch being processed for the determination of equivalence of the Content Uniformity of content for individual assessment of the drug in a number of dosage units. The quantification was performed by UV spectrophotometry at 290 nm. The results were expressed in percentages by comparing the equivalent (average) between batches (A, B and C), respectively being 100.06%, 98.58% and 100.16%, the values are within the ranges set by the USP XXXII. The analysis of variance and no significant clinical difference at 95% significance, leads to establish that the tablets of batches A and C contained an equivalent amount of active ingredient (100.31% and 100.32%), unlike the group B ( 98.98%). We conclude that the three lots of pyridoxine hydrochloride tablets 50 mg are equivalent