Development of electrochemical and stability-indicating chromatographic methods for the determination of cefprozil


Ortak A., Erkmen C., BOZAL PALABIYIK B., USLU B.

Journal of the Iranian Chemical Society, vol.21, no.1, pp.263-273, 2024 (SCI-Expanded) identifier

  • Publication Type: Article / Article
  • Volume: 21 Issue: 1
  • Publication Date: 2024
  • Doi Number: 10.1007/s13738-023-02923-6
  • Journal Name: Journal of the Iranian Chemical Society
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier
  • Page Numbers: pp.263-273
  • Keywords: Cefprozil, Drug analysis, HPLC, Validation, Voltammetry
  • Hacettepe University Affiliated: No

Abstract

This study aims to develop an electrochemical method for determining cefprozil (CFP) and a stability-indicating chromatographic analysis method for determining CFP’s isomers. CFP was determined for the first time via voltammetric methods in this study. The electrochemical behavior of CFP was examined over a pH ranging between 0.3 and 10.0 using cyclic voltammetry and differential pulse voltammetry (DPV). CFP oxidized irreversibly and by diffusion-controlled at a glassy carbon electrode. Quantification studies with DPV were carried out. The repeatability, reproducibility, sensitivity, precision, and accuracy of the method were statistically evaluated. To determine CFP's diastereoisomers, a high-performance liquid chromatography (HPLC) method was devised and validated using paracetamol as the internal standard. The moving phase, buffer solutions at various concentrations, pH, temperature, and flow rate impacts were all tuned in the experiments. The optimum separation via chromatography was sustained through the ACE 5 C8 (150 × 4.6 mm × 5 µm) column and acetonitrile: buffer solution (5 mM, ammonium acetate), 90:10 (v/v) mobile phase composition. The CFP diastereomers were separated at a flow rate of 1 mL min−1, 45 °C, and a wavelength of detection at 280 nm. The proposed method was validated in line with the International Conference on Harmonization guidelines, and HPLC degradation studies (oxidation, UV light, acid, base and temperature) were also performed. The proposed voltammetric and stability-indicating chromatographic methods have been successfully applied in pharmaceutical dosage forms. Thus, it has been shown that the analysis results were not affected by the excipients and their applicability to drug samples. Both methods were validated, and their applicability for analysis from synthetic biological samples will be demonstrated. The developed methods were fast, selective, sensitive, reliable, and environmentally friendly.