Novel RP-HPLC method development and validation for the estimation of Ceftriaxone sodium sterile in bulk and its formulations

A simple, specific, accurate, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Ceftriaxone Sodium Sterile in pharmaceutical dosage forms. The chromatographic separation was done on Phenomenex Luna reversed phase C18 (250 mm x 4.6 mm, 5 ìm) column in isocratic mode, with mobile phase containing HPLC grade Acetonitrile: Phosphate buffer at pH 6.8 (10:90, v/v) was used. The flow rate was 1 ml / min and effluents were monitored at 254 nm. Chromatogram showed a main peak of Ceftriaxone Sodium Sterile at retention time was 3.093 min. The concentration range was 3-18 μg/ml with correlation coefficient 0.999. The method was validated for linearity, accuracy, precision, and limit of detection, limit of Quantitation, robustness and ruggedness. The limit of detection and limit of Quantitation for estimation of Ceftriaxone Sodium Sterile was found to be 0.192585 and 0.583592 μg/ml respectively. Recovery of Ceftriaxone Sodium Sterile was found in the range of 98.0-102.0%. Proposed method was successfully applied for the quantitative determination of Ceftriaxone Sodium Sterile in its pharmaceutical dosage forms.