RP-HPLC Method for Simultaneous Estimation of Cefepime Hydrochloride and Tazobactam Sodium in Bulk and Pharmaceuticals

الملخص EN

A precise, accurate, sensitive and robust RP-HPLC method was developed for cefepime hydrochloride and tazobactam sodium in bulk and pharmaceutical formulation.

Chromatographic separation was achieved on PrincetonSPHER-100 C-18 column (250 mm × 4.6 mm i.d., 5 µm) at ambient temperature.

A binary mobile phase consisting of 25 mM potassium dihydrogen phosphate buffer, pH 6.2 and acetonitrile (94 : 6, v/v) was delivered through a column at a flow rate of 1 mL/min.

Measurement was performed at a wavelength 210 nm.

The method was linear over the concentration range of 4–24 µg/mL (r2=0.9977) for cefepime and 0.5–3.0 µg/mL (r2=0.9974) for tazobactam.

The percentage content found for cefepime was 101.12 ± 0.49 and for tazobactam was 101.33 ± 1.17 in the pharmaceutical formulation.

The method was validated for linearity, precision, accuracy, sensitivity and robustness as per ICH Q2 (R1) guideline.