A VALIDATED STABILITY INDICATING HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF CEFPODOXIME PROXETIL AND POTASSIUM CLAVULANATE IN BULK AND TABLET DOSAGE FORM

• Published in: Journal of liquid chromatography & related technologies Vol. 33; no. 18; pp. 1689 - 1703
• Main Authors: Thomas, A. B., Dighe, S. B., Nanda, R. K., Kothapalli, L. P., Jagdale, S. N., Deshpande, A. D.
• Format: Journal Article
• Language: English
• Published: Colchester Taylor & Francis Group 29.10.2010; Taylor & Francis
• Subjects: Analysis; Biological and medical sciences; cefpodoxime proxetil; forced degradation; General pharmacology; high-performance thin-layer chromatography; Medical sciences; Pharmacology. Drug treatments; potassium clavulanate; stability-indicating method; validation; Chemical analysis; Chemical stability; Lactam; high-performance thin-layer chromatography; β-Lactamase; Thermal stability; Bulk material; Bicyclic compound; Tablet; Densitometry; Quantitative analysis; Cefpodoxime; Oxygen nitrogen heterocycle; Validation; Sulfur nitrogen heterocycle; Enzyme; Enzyme inhibitor; Oral form; cefpodoxime proxetil; Thin layer chromatography; Cephalosporin derivatives; Antibiotic; Ultraviolet detector; potassium clavulanate; Storage stability; Quality control; Simultaneous measurement; Dosage form; Photochemical stability; Hydrolases; forced degradation; Antibacterial agent; stability-indicating method; Degradation product
• ISSN: 1082-6076; 1520-572X
• DOI: 10.1080/10826076.2010.519255

Cefpodoxime proxetil (Cef) and Potassium clavulanate (Pot.clav.) are used in the treatment of acute otitis media, typhoid fever, pharyngitis and tonsillitis. A simple, selective and stability indicating HPTLC method has been established for the simultaneous analysis of Cef and Pot.clav. in pharmaceutical formulations. The method uses aluminum-backed silica gel 60F 254 HPTLC plates as stationary phase with toluene:methanol:chloroform:acetonitrile [4:3:2:1.5 (v/v/v/v)] as mobile phase with densitometric analysis at 278.0 nm. This system was found to give compact bands for Cef and Pot.clav. with Rf values 0.72 ± 0.02 and 0.33 ± 0.02 respectively. Linear relationships were obtained between response and amount of drug with high correlation coefficients (r 2 ) in the range 250-3500 ng band −1 for Cef (r 2  = 0.9951) and 100-4500 ng band −1 for Pot.clav. (r 2  = 0.9930). Inter and intraday RSD values for Cef were 0.523% and 0.530% respectively and 0.401% and 0.355% for Pot.clav. respectively. Total recoveries of Cef and Pot.clav. from the tablet formulations were 99.78% and 99.96% respectively. The LOD and LOQ were 24.29 and 73.60 ng band −1 for Cef, 16.7 and 50.61 ng band −1 for Pot.clav. respectively. Cef and Pot.clav. were subjected to forced degradation studies. The degradation products obtained were well resolved from the pure drugs with significantly different Rf values. As the method could effectively separate the drugs from its degradation products, it can be used for stability-indicating analysis.