title: Validated stability-indicating high-performance thin-layer chromatographic method for estimation of cefpodoxime proxetil in bulk and in pharmaceutical formulation according to International conference on harmonization guidelines.
abstract: OBJECTIVE
  A simple, selective, precise, and stability-indicating high-performance thin-layer chromatographic (HPTLC) method for analysis of cefpodoxime proxetil both in bulk and in pharmaceutical formulation has been developed and validated.
  
  
  METHODS
  The method employed HPTLC aluminum plates precoated with silica gel 60 RP-18 F(254) as the stationary phase. The solvent system consisted of toluene:methanol:chloroform (4:2:4 v/v). The system was found to give compact spot for cefpodoxime proxetil (R(f) value of 0.55 ± 0.02). Densitometric analysis of cefpodoxime proxetil was carried out in the absorbance mode at 289 nm.
  
  
  RESULTS
  The linear regression analysis data for the calibration plots showed good linear relationship, with r(2) = 0.998 ± 0.0015 with respect to peak area in the concentration range of 100-600 ng per spot. The mean value±SD of slope and intercept were 3.38 ± 1.47 and 986.9 ± 108.78 with respect to peak area. The method was validated for precision, recovery, and robustness. The limits of detection and quantification were 3.99 and 12.39 ng per spot, respectively. Cefpodoxime proxetil was subjected to acid and alkali hydrolysis, oxidation, and thermal degradation. The drug undergoes degradation under acidic and basic conditions, indicating that the drug is susceptible to both acid and base. The degraded product was well resolved from the pure drug, with significantly different R(f) value. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of the investigated drug.
  
  
  CONCLUSIONS
  The proposed HPTLC method can be applied for identification and quantitative determination of cefpodoxime proxetil in both bulk drug and pharmaceutical formulation.
authors.affiliation: Department of Pharmaceutical Chemistry, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, India.
authors.forename: Pritam
authors.initials: P
authors.lastname: Jain
authors.forename: Amar
authors.initials: A
authors.lastname: Chaudhari
authors.forename: Anup
authors.initials: A
authors.lastname: Bang
authors.forename: Sanjay
authors.initials: S
authors.lastname: Surana