RT info:eu-repo/semantics/bachelorThesis
T1 Validación de un método espectrofotométrico para la determinación de levofloxacino.
A1 Sánchez García, Ignacio
K1 Quinolones, Levofloxacino, Calidad de medicamentos.
AB Levofloxacin (LFX) is an antibiotic drug used in many pathologies, includingtuberculosis, and it is marketed in solid oral dosage forms such as tablets or capsules.Although the method of choice for estimating the amount of said active ingredient is highperformance liquid chromatography (HPLC), the development of alternative or paralleldetermination techniques, such as ultraviolet-visible (UV/VIS) spectrophotometry, are ofgreat interest to reduce not only costs, but also the difficulty of quality control processesof the pharmaceutical specialties of this drug.The present study takes as reference different works of validation and of analyticalmethods that use the aforementioned technique to the quantitative determination of LFXin acid solutions with HCl 0.1M as diluent by UV/VIS spectrophotometry. It wasachieved a calibration curve that was statistically studied by an analysis of varianceANOVA, studies of precision, accuracy, and repeatability. This analysis techniquefollowed the standards present in the guide ICH Q2(R1) of The International Council forHarmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).Results: UV/VIS spectrophotometry analysis at a wavelength of 294 nm exhibited acorrelation coefficient of 0.9978 in a concentration range from 2.0 to 9.0 µg/mL. Theequation of the regression curve was y = 0.0864 * x. The average recovery was 100.91%,while the coefficient of variation (CV) remained at 0.16%. The limit of detection andlimit of quantitation were 0.539 and 1.634 µg/mL, respectively. It was concluded that thedeveloped method is suitable for the quality control of levofloxacin and it is fast, simplewith high precision and accuracy.
YR 2020
FD 2020
LK http://riull.ull.es/xmlui/handle/915/20463
UL http://riull.ull.es/xmlui/handle/915/20463
LA es
DS Repositorio institucional de la Universidad de La Laguna
RD 18-dic-2024