Green gas chromatographic stability-indicating method for the determination of Lacosamide in tablets. Application to in-vivo human urine profiling.
J Chromatogr B Analyt Technol Biomed Life Sci
; 1083: 75-85, 2018 Apr 15.
Article
en En
| MEDLINE
| ID: mdl-29524696
ABSTRACT
A direct, eco-friendly, stability-indicating GC method was developed for the determination of Lacosamide (LCM) in tablet dosage forms in presence of its degradation products as well as in human urine in presence of the co-administered drug Zonisamide (ZON). The assay method in tablets was validated according to the ICH guidelines, while the method for determination of LCM in urine was validated according to FDA; Bioanalytical Method Validation guidance. Linear response (râ¯=â¯0.9998) was observed over the range of 20-280⯵g/mL of LCM, with detection and quantitation limits of 5.871 and 19.57⯵g/mL, respectively for the tablet assay method. While (râ¯=â¯0.9999) was observed over the range of 0.5-20⯵g/mL of LCM, with detection and quantitation limits of 67 and 233â¯ngâ¯mL-1, respectively for the urine analysis method. Under various stress conditions, the investigation of LCM forced degradation behaviour was carried out. Furthermore, monitoring of the drug in urine followed by construction of its urine profile was done after the administration of 50â¯mg tablet of LCM to three healthy volunteers so as to prove the ability of the method to be applied in assaying LCM in human urine. The method showed also successful separation of LCM and the co-administered drug ZON in urine. Finally, the greenness of the method was assessed using National Environmental Methods Index label and Eco scale methods.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Cromatografía de Gases
/
Acetamidas
Tipo de estudio:
Prognostic_studies
Límite:
Adult
/
Humans
/
Male
Idioma:
En
Revista:
J Chromatogr B Analyt Technol Biomed Life Sci
Asunto de la revista:
ENGENHARIA BIOMEDICA
Año:
2018
Tipo del documento:
Article
País de afiliación:
Egipto