Development and Validation of RP-HPLC Method for the Quantitative Estimation of Cefadroxil Monohydrate in Bulk and Pharmaceutical Dosage Forms

Author(s): Arshad Anjum, Sathish Kumar A. Shetty, Manzoor Ahmed, B. K. Sridhar and M. L. Vijaya Kumar

A simple, precise, specific and accurate RP-HPLC method has been developed for the determination of cefadroxil monohydrate in bulk and pharmaceutical dosage forms. Chromatography was performed on a supelco RP C-18 column (250 mm × 4.6 mm) with 5 μm particle size. The mobile phase consists of two solvents methanol and 0.05M disodium hydrogen orthophosphate buffer (60 : 40 v/v) and with pH 3.0 adjusted with orthophosphoric acid. At a flow rate of 0.75 mL/min. Detection was performed at 264 nm. The retention time of cefadroxil monohydrate was found to be 4.108 min. By adoption of this procedure cefadroxil monohydrate is eluted completely. Linear calibration plots were obtained between 20-100 μg/mL. The method of analysis was used for quantification in pharmaceutical preparations with a coefficient of variation < 2%. Results of analysis were validated statistically and by recovery studies. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.

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