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THE PHARMA REVIEW (MAY - JUNE 2011)

A Validated RP-HPLC Method for Analysis of Cefadroxil and Potassium Clavulanate as the Bulk Drugs and in Combined Tablet Dosage Forms

Vasudha B. Pisal, Padmanabh B. Deshpande, Santosh V. Gandhi, Yogeshwari Bhangale

Abstract: Cefadroxil is an orally active semisynthetic β lactam antibiotic, used in the treatment of Gram positive and Gram negative bacteria and Potassium Clavulanate is a powerful inhibitor of β lactamase enzyme and is most often formulated in combination with antibiotic to treat infection caused by β lactamase producing bacteria. This paper describes a simple, accurate, sensitive and validated RP-HPLC method for simultaneous quantification of these compounds as the bulk drug and in tablet dosage forms. Separation was carried out on Jasco HPLC system equipped with Neosphere C18 column (150 x 4.6 mm i.d.) and UV/VIS detector using Methanol: 20 mM potassium dihydrogen phosphate buffer in ratio of (10: 90, v/v) as mobile phase and detection was carried out at 220 nm. Results were linear in the range of 5-30 g/ml for Cefadroxil and 2-12 g/ml for Potassium Clavulanate. The method has been successfully applied for determining the assay and in-vitro dissolution of marketed formulation. Results of analysis were validated statistically and by recovery studies.
Introduction
Cefadroxil,(6R,7R)-7-[(2R)-2-Amino-2-(4-hydroxyphenyl)acetylamino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylicacidis β lactamantibiotic from cephalosporin group effective against urinary tract infection as well as pharyngitis and laryngitis.1 Potassium Clavulanate, chemically, Monopotassium(2R,5R)-3-[(1Z)-2-hydroxyethylidene]-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate is a naturally occurring β-lactamase inhibitor used for the treatment of infection caused by β-lactamase producing bacteria that are resistant to Cefadroxil alone.2
Literature survey reveals High Performance Liquid Chromatographic (HPLC) methods for determination of Cefadroxil as single and in combination with other drugs.3-6 Also Spectrophotometric methods for determination of Cefadroxil as single and in combination with other drugs in dosage form have been also reported.7-10 HPLC methods in human plasma, biological fluids in combination with other drugs have been reported for the determination of Potassium Clavulanate.11-17 Densiometric method for simultaneous estimation of Potassium Clavulanate with other drugs has also been reported.18 To best of our knowledge no reports were found for the simultaneous estimation of the Cefadroxil and Potassium Clavulanate in combined dosage form by HPLC method. This paper describes a simple, accurate, sensitive and validated RP-HPLC method for simultaneous quantification of these compounds as the bulk drug and in tablet dosage forms. The proposed method is optimized and validated as per the International Conference on Harmonization (ICH) guidelines.19

 

 

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