HPTLC Determination of Cefpodoxime Proxetil and Potassium Clavulanate in Combined Tablet Dosage Form

S. V. Gandhi, P. B. Deshpande, U. P. Patil, P. J. Mundhe, P. R. Deshmukh

Abstract: A simple, specific, accurate and precise high-performance thin-layer chromatographic method for simultaneous estimation of Cefpodoxime proxetil and Potassium clavulanate in combined tablet dosage form has been developed. The drugs were separated on aluminium plates precoated with silica gel 60 F254 using chloroform–methanol–toluene (4:3:3 v/v/v) as mobile phase. Quantitative analysis was performed by densitometric scanning at 215 nm. The two drugs were satisfactorily resolved with Rf values 0.66 ± 0.012 and 0.16 ± 0.004 for cefpodoxime proxetil and potassium clavulanate, respectively. The method was validated for linearity, accuracy, precision, specificity and robustness. The calibration plot was linear over the ranges 500–2500 and 2000–10000 ng/band for cefpodoxime proxetil and potassium clavulanate, respectively. This method has been successfully applied for the analysis of drugs in a pharmaceutical formulation. The % assay was found to be 99.17 ± 0.657 for cefpodoxime proxetil and 100.70 ± 1.427 for potassium clavulanate (Mean ± S.D).

Cefpodoxime proxetil is an oral third generation cephalosporin antibiotic widely used in treatment of variety of skin, respiratory, urinary tract and systemic infections.1 Clavulanic acid administered as potassium salt is a powerful inhibitor of β-lactamase enzyme and is often formulated in combination with antibiotics for treatment of infection caused by lactamase producing bacteria.2

Literature survey reveals several HPLC methods for the determination of cefpodoxime proxetil in plasma, sinus mucosa, urine and in pharmaceutical dosage form as a single drug or in combination with other drugs.3-6 HPTLC methods have been reported for the estimation of cefpodoxime proxetil in pharmaceutical formulation.7,8 Several HPLC methods have been reported for estimation of potassium clavulanate in combination with other drugs.9-15 No reports were found for the simultaneous estimation of the cefpodoxime proxetil and potassium clavulanate in combined tablet dosage form by HPTLC method. This paper describes a simple, specific, accurate, precise and sensitive HPTLC method for determination of cefpodoxime proxetil and potassium clavulanate in combined tablet dosage form. The proposed method was optimized and validated in accordance with International Conference on Harmonization (ICH) guidelines.16


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