Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil

An isocratic RP-HPLC method was developed for the determination of Cefditoren pivoxil in pharmaceutical formulations using a C-18 column with water–acetonitrile (50:50, v/v) as mobile phase and flow rate 1.2 mL/min (UV detection at 218 nm). Linearity was observed in the concentration range 1.0–250 μ...

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Detalles Bibliográficos
Autores principales: Annapurna, M. Mathrusri, Goutam, S.V.S., Anusha, S., Srinivas, L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Xi'an Jiaotong University 2012
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5760946/
https://www.ncbi.nlm.nih.gov/pubmed/29403785
http://dx.doi.org/10.1016/j.jpha.2012.06.003
Descripción
Sumario:An isocratic RP-HPLC method was developed for the determination of Cefditoren pivoxil in pharmaceutical formulations using a C-18 column with water–acetonitrile (50:50, v/v) as mobile phase and flow rate 1.2 mL/min (UV detection at 218 nm). Linearity was observed in the concentration range 1.0–250 μg/mL (R(2)=0.999) with regression equation y=24194x+10749. The forced degradation studies were performed by using HCl, NaOH, and H(2)O(2), and thermal and UV radiation. Cefditoren pivoxil is more sensitive towards oxidation and alkaline conditions and resistant towards acidic and photolytic degradations. The method was validated as per ICH guidelines.

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