Development and validation of the stability-indicating LC–UV method for the determination of Cefditoren pivoxil
نویسندگان
چکیده
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.
منابع مشابه
Development and Validation of a Stability-Indicating Liquid Chromatographic Method for the Determination of Cefditoren Pivoxil in Presence of Degradation Products
A novel stability indicating liquid chromatographic method was developed for the determination of Cefditoren pivoxil in presence of degradation products using Zorbax SB C18 (150 mm × 4.6 mm i.d., 3.5 μm particle size) column with a flow rate 1.0 mL/min (UV detection 210 nm). Linearity was observed over a concentration range 0.1–200 μg/mL with regression equation y = 34809 x + 30603 (R = 0.9994)...
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