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Simple chromatographic methods for determination of cefepime in bulk powder and injection dosage form, and in presence of its hydrolytic degradation products

Omar Abdel-Aziz, Maha Farouk, Reham Nagi, Laila Abdel-Fattah

The present work describes development and validation of stability indicating HPTLC-densitometric and HPLC methods for quantitative analysis of cefepime in bulk and injection dosage form. InHPTLC, separation was performed on silica gel 60 F254 using diethylether-ethanol-water-glacial acetic acid (5: 3: 2: 0.05, v/v) as a developing system. The compact band of cefepime at Rf 0.14±0.02 was scanned densitometrically at 257nm and calibration curve was constructed in the range of 0.60-8.00 µg/spot using polynomial regression function. The proposed RP-HPLC method utilizes an isocratic elution on C18 column with mobile phase consisting ofmethanol: water (30:70, v/v) at ambient temperature and a flow rate of 1.2 ml/min. The chromatographic run timewas less than 5min. Quantificationwas achievedwithUV detection at 257nm over concentration range of 0.60 to 20.00 µg/ml. Cefepime was subjected to acid and alkaline induced hydrolytic degradation. Themethods distinctly separated it fromits degradation products, which infers the specificity of assay methods for estimation of cefepime in the presence of its hydrolytic degradation products. Due to simplicity, rapidity and accuracy of the proposed stability indicating methods, they are effective for quality control analysis.