Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR THE ESTIMATION OF CEFPODOXIME PROXETIL AND DICLOXACILLIN SODIUM IN TABLET DOSAGE FORM

Sneh N. Patel*, Kamlesh R. Prajapati and Professor Dr. Dhrubo Jyoti Sen

ABSTRACT

A simple, precise and accurate isocratic stability–indicating RP–HPLC method was developed and validated for the simultaneous determination of Cefpodoxime Proxetil and Dicloxacillin Sodium in commercial tablets. The method has shown adequate separation for Cefpodoxime Proxetil and Dicloxacillin Sodium from their degradation products. Separation was achieved on a Waters C18 (250 mm × 4.6 mm i.d., 5 μm particle size) column using a mobile phase consisting of Acetonitrile – 20 mM Ammonium Acetate Buffer (42:58 v/v) at flow rate of 1 mL/min and UV detection at 235 nm. This drugs were subjected to hydrolysis, oxidation, photolysis and heat to apply stress conditions. The linearity was investigated in the range of 5–25 μg/mL (r2 = 0.9993) for Cefpodoxime Proxetil and 12.5–62.5 μg/mL (r2 = 0.9991) for Dicloxacillin Sodium. The LOD were 0.10 μg/mL and 0.68 μg/mL for Cefpodoxime Proxetil and Dicloxacillin Sodium, respectively. The LOQ were 0.33 μg/mL and 2.06 μg/mL for Cefpodoxime Proxetil and Dicloxacillin Sodium, respectively.

Keywords: RP-HPLC, Cefpodoxime Proxetil, Dicloxacillin Sodium, Stability Indicating Assay Method.