alexa Abstract | Development and Validation of HPLC Method for Simultaneous Estimation of Ceftriaxone and Sulbactam in Pharmaceutical Dosage Form


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Research Article Open Access

Abstract

A simple, precise, sensitive and accurate High Performance Liquid Chromatography method was developed for the estimation of Ceftriaxone and Sulbactam in pharmaceutical dosage form to create an affordable and reliable method. The sample was analyzed with BDS hypersil C18 column (250*4.6mm and 5 μm) thermo scientific in isocratic mode, using a mobile phase containing Phosphate buffer (pH3.5): Methanol in the ratio of 60:40 v/v at a flow rate of 1.0ml/min. The analyte were detected at 277 nm. The retention times were found to be 3.960 min and 6.220 min for Ceftriaxone and Sulbactam respectively. As per ICH guideline the method was validated. Linearity of Ceftriaxone was found in the range 10-30 μg/ml (R2=0.999) and that for the Sulbactam was found to be 5-15 μg/ml (R2=0.998).The accuracy of the present method was evaluated at 80%, 100% and120%. Recovery was found to be in the range 99.56- 99.61% and 99.52-99.93% for Ceftriaxone and Sulbactam respectively. Intermediate precision studies were carried out and the % RSD values were less than two. The method is found to be robust since the retention times and tailing factors were within the limits even after little deliberate variations in pH, flow rate and mobile phase ratio. The values of LOD and LOQ were found to be 0.694μg/ml and2.105μg/ml for Ceftriaxone and 0.828 μg/ml and2.510μg/ml for Sulbactam. This demonstrates that the developed method is simple, precise, sensitive, accurate and robust for simultaneous estimation of Ceftriaxone and Sulbactam in pharmaceutical dosage form.

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Keywords

Ceftriaxone sodium, HPLC, method development, sulbactam sodium, validation, Pharmaceutical Sciences

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