HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF CEFIDEROCOL IN BULK AND PHARMACEUTICAL DOSAGE FORMS
Anil Kumar, Ravindra Kumar Chourasiya
ABSTRACT
A simple, rapid, and sensitive High-Performance Liquid Chromatography (HPLC) method was developed and validated for the estimation of Cefiderocol in bulk drug and injectable dosage forms. The separation was achieved using a mobile phase of 10 mM KH?PO?: Methanol (20:80 v/v), pH adjusted to 4.0 with orthophosphoric acid, at a flow rate of 1.0 mL/min, with detection at 258 nm. The method showed good linearity over the concentration range of 5–25 µg/mL (r² = 0.9993). System suitability parameters, including retention time, tailing factor, and number of theoretical plates, were within acceptable limits. Accuracy was confirmed through recovery studies (98.28–98.85%), and precision studies demonstrated low %RSD values, indicating excellent repeatability and intermediate precision. The method was robust and sensitive, with LOD and LOQ values of 0.15 µg/mL and 0.45 µg/mL, respectively. Forced degradation studies under acidic, alkaline, oxidative, and photolytic conditions confirmed the stability-indicating nature of the method. The developed HPLC method is reliable, accurate, and suitable for routine quality control and stability analysis of Cefiderocol in pharmaceutical formulations.
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