Using and validation of a novel spectrophotometric method for determination of ceftriaxone sodium in pharmaceutical dosage forms via its complexation with Cu (II)

A simple, accurate and sensitive UV-Visible spectrophotometric method have been used and validated for the quantitative determination of ceftriaxone sodium in either pure form or in its pharmaceutical vials. The method is based on the formation of a complex with copper(II). Appropriate conditions were examined for the reaction to obtain maximum absorptivity and sensitivity. Under the optimum reaction conditions, linear relationship with good correlation coefficient (0.999) was found between the concentrations and the absorbance of the formed complex. The color of the produced complex is measured at 635nm. The molar absorptivity is 1.16× 10 4L mol-1cm-1and Sandell s sensitivity is 0.057μg/cm2. The method is applicable over concentration range of 8 – 70 μg/ml. The results of analysis have been validated statistically, and recovery studies confirmed the accuracy of the proposed method which was carried out by following the ICH guidelines. Furthermore, the developed method hold its accuracy and precision well when applied to the determination of ceftriaxone sodium in its pharmaceutical vials.