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Abstract

A reverse phase high performance liquid chromatographic (HPLC) method was developed for the assay of Cefditoren pivoxil in bulk forms and tablet dosage formulations. Isocratic separation was achieved on Nucleosil 100-5 C18 column (250mm×4.6mm i.d.,5mm particle size) using a mobile phase of water: methanol in the in ratio (20:80), pH 6.0 adjusted with 10% v/v ortho phosphoric acid at a flow rate of 1.0 ml/min and UV detection at 256 nm. retention time of 3.65 min with sharp symmetrical peak. The method was validated for specificity, linearity, solution stability, accuracy and precision. Accuracy of the proposed method was ascertained on the basis of recovery studies by standard addition method with standard deviation of 0.347 and coefficient of variation 0.348 suggesting good recovery. The drug was subjected to hydrolysis, oxidation, photolysis and dry heat to apply stress conditions. Complete separation was archived for the parent drug and the degradation products, with overall run time of 15 min with parent compound eluting at approximately at 3.65 min. The method was successfully used for analysis of Cefditoren pivoxil in bulk and tablet dosage form, and subsequent study of stability samples.

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	JPR Solutions

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