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

Abstract

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 60F₂₅₄ 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 (r²) in the range 250–3500 ng band⁻¹ for Cef (r² = 0.9951) and 100–4500 ng band⁻¹ for Pot.clav. (r² = 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.

Keywords:

• cefpodoxime proxetil
• forced degradation
• high-performance thin-layer chromatography
• potassium clavulanate
• stability-indicating method
• validation

ACKNOWLEDGEMENTS

The authors express their gratitude to Pad. Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pune, MH, India, for providing necessary infrastructural facilities and to Emcure Pharmaceutical, India, for the generous gift samples of pure Cef and Pot.clav.

Notes

*Denotes average of six estimations.

*Denotes average of six estimations.

*Denotes average of six estimations.

**Denotes average of three estimations at each level of recovery.