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

M Mathrusri Annapurna; S V S Goutam; S Anusha; L Srinivas

doi:10.1016/j.jpha.2012.06.003

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

J Pharm Anal. 2012 Dec;2(6):466-469. doi: 10.1016/j.jpha.2012.06.003. Epub 2012 Jun 27.

Authors

M Mathrusri Annapurna¹, S V S Goutam¹, S Anusha¹, L Srinivas¹

Affiliation

¹ Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam 530045, India.

Abstract

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 (R²=0.999) with regression equation y=24194x+10749. The forced degradation studies were performed by using HCl, NaOH, and H₂O₂, 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.

Keywords: Cefditoren pivoxil; Liquid chromatography; Stability-indicating; Validation.