High Performance Thin Layer Chromatographic Determination of Potassium Clavulanate and Cefadroxil in Combined Tablet Dosage Form

A new simple High Performance Thin Layer Chromatographic (HPTLC) method for determination of Potassium Clavulanate and Cefadroxil in combined tablet dosage form has been developed and validated. The mobile phase selected was Methanol: Ethyl acetate: Formic acid (1.5: 8: 0.8, v/v/v) with UV detection at 230 nm. The retention factor for Potassium Clavulanate and Cefadroxil were found to be 0.77 ± 0.011 and 0.39 ± 0.007, respectively. The method was validated with respect to linearity, accuracy, precision and robustness as per the International Conference on Harmonisation (ICH) guidelines. Results found to be linear in the concentration range of 2000-12000 ng/band for Potassium Clavulanate and 500-3000 ng/band for Cefadroxil respectively. The method has been successfully applied for the analysis of drugs in pharmaceutical formulation. The % assay (Mean ± S.D.) was found to be 100. 06 ± 0.916 for Cefadroxil and 99.93 ± 0.996 for Potassium Clavulanate. The method can be used for routine analysis of these drugs in combined tablet dosage forms in quality-control laboratories.

Author(s): Vasudha B. Pisal, Padmanabh B. Deshpande, Santosh V. Gandhi, Yogeshwari Bhangale

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