title: A developed and validated stability-indicating reverse-phase high performance liquid chromatographic method for determination of cefdinir in the presence of its degradation products as per International Conference on Harmonization guidelines.
abstract: The present article deals with the development and validation of a stability-indicating, reverse-phase high performance liquid chromatographic (RP-HPLC) method, for the determination of cefdinir on a Waters RP Spherisorb C-18 column (250 mm × 4.6 mm, 5 μm). A mobile phase consisting of water (pH adjusted to 3.0 with orthophosphoric acid) : acetonitrile : methanol 13:5:2 (v/v/v) was used. The flow rate was 1 mL min(-1). The separation was performed at room temperature. Detection was carried out at 286 nm, using a PDA detector. The developed method was statistically validated for the linearity, accuracy, specificity, Limit of Detection (LOD), and Limit of Quantitation (LOQ). The specificity of the method was ascertained by forced degradation studies, by acid and alkali degradation, oxidation, photolysis, and heat degradation. The degraded products were well-separated from the analyte, with significant differences in their retention time values. The Beer Law was obeyed over a concentration range of 0.05 - 15.00 μg mL(-1) and the correlation coefficient was 0.999.
authors.affiliation: Department of Pharmaceutical Analysis, Principal K. M. Kundnani College of Pharmacy, Jote Joy Building, Colaba, Mumbai, India.
authors.forename: Purnima
authors.initials: P
authors.lastname: Hamrapurkar
authors.forename: Priti
authors.initials: P
authors.lastname: Patil
authors.forename: Mitesh
authors.initials: M
authors.lastname: Phale
authors.forename: Mital
authors.initials: M
authors.lastname: Gandhi
authors.forename: Sandeep
authors.initials: S
authors.lastname: Pawar
keywords: Cefdinir; degradation products; reverse-phase high performance liquid chromatographic; validation