Validación de un método espectrofotométrico para la determinación de levofloxacino.

Abstract

Levofloxacin (LFX) is an antibiotic drug used in many pathologies, including tuberculosis, 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 parallel determination techniques, such as ultraviolet-visible (UV/VIS) spectrophotometry, are of great interest to reduce not only costs, but also the difficulty of quality control processes of the pharmaceutical specialties of this drug. The present study takes as reference different works of validation and of analytical methods that use the aforementioned technique to the quantitative determination of LFX in acid solutions with HCl 0.1M as diluent by UV/VIS spectrophotometry. It was achieved a calibration curve that was statistically studied by an analysis of variance ANOVA, studies of precision, accuracy, and repeatability. This analysis technique followed the standards present in the guide ICH Q2(R1) of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Results: UV/VIS spectrophotometry analysis at a wavelength of 294 nm exhibited a correlation coefficient of 0.9978 in a concentration range from 2.0 to 9.0 µg/mL. The equation 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 and limit of quantitation were 0.539 and 1.634 µg/mL, respectively. It was concluded that the developed method is suitable for the quality control of levofloxacin and it is fast, simple with high precision and accuracy.