Analyzing Thermal Degradation of Furvina Drug Using a Stability Indicating Spectrophotometric Method and Characterization Studies
Por:
Luis Valdes-Negrin, Hector, Alvarez, Orlando, Perez-Rodriguez, Zenia, Rodriguez-Negrin, Zenaida, Perez-Rodriguez, Michael
Publicada:
1 abr 2022
Resumen:
Furvina is a potential compound for preclinical research, and therefore
it is required to understand how environmental factors can affect its
stability. In this work, the thermal stability and degradation kinetics
of the furvina drug were investigated using a reliable
spectrophotometric method. To reach this goal, three random furvina
samples were submitted under conditions of thermal stress varying the
temperature from 60 to 90 degrees C with a gradual increase of 10
degrees C as a function of time. The current method was validated over
the concentration range of 1 to 30 mu g mL(-1), with limits of detection
(LOD) and quantification (LOQ) of 0.14 and 0.47 mu g mL(-1),
respectively. Fortifications made on heat-treated furvina samples
achieved precisions less than 6.0% and accuracies in the range
97.8-102.5%, indicating the effectiveness of the proposed method for
drug evaluation. Temperature showed a significant effect on furvina
stability showing a tendency to gradually decrease its performance by
increasing exposure time, which was confirmed by DSC, FT-IR, and SEM
analysis. This compound was degraded around 10% when exposed to 90
degrees C for 6 h complying with the reasonable degradation limits
established by Centro para el Control Estatal de Medicamentos, Equipos y
Dispositivos Medicos (CECMED) and International Conference on
Harmonisation (ICH) regulations. The degradation behavior of furvina
followed first-order kinetics associated with a correlation coefficient
of 0.9924. Our findings will enable to better understand the thermal
stability of furvina, with the goal of proposing potential applications
in the pharmaceutical industry.
Filiaciones:
Luis Valdes-Negrin, Hector:
Univ Cent Marta Abreu las Villas UCLV, Ctr Bioactivos Quim, Carretera Camajuani Km 5 1-2 Villa Clara, Santa Clara 54830, Cuba
Alvarez, Orlando:
Univ Cent Marta Abreu las Villas UCLV, Ctr Bioactivos Quim, Carretera Camajuani Km 5 1-2 Villa Clara, Santa Clara 54830, Cuba
Perez-Rodriguez, Zenia:
Univ Cent Marta Abreu las Villas UCLV, Ctr Bioactivos Quim, Carretera Camajuani Km 5 1-2 Villa Clara, Santa Clara 54830, Cuba
Rodriguez-Negrin, Zenaida:
Univ Cent Marta Abreu las Villas UCLV, Ctr Bioactivos Quim, Carretera Camajuani Km 5 1-2 Villa Clara, Santa Clara 54830, Cuba
Perez-Rodriguez, Michael:
Univ Cent Marta Abreu las Villas UCLV, Ctr Bioactivos Quim, Carretera Camajuani Km 5 1-2 Villa Clara, Santa Clara 54830, Cuba
Univ Nacl Autonoma Mexico, Fac Quim, Dept Quim Analit, Av Univ 3000, Ciudad De Mexico 04510, Mexico
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