Fully investigation of rp-hplc analytical method validation parameters for determination of cefixime traces in the different pharmaceutical dosage forms and urine analysis

Mostafa F. Al-Hakkani*, Gamal A. Gouda, Sedky H.A. Hassan, Osman A. Farghaly, Mahmoud M.A. Mohamed

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)

Abstract

Cefixime (Cfx) is a member of the third generation of Cephalosporin antibiotics. It used on a wide scale in prescribed antibiotic drugs as anti-infection for Gram-positive and Gram-negative microorganisms. The present study aimed to develop an HPLC method of Cfx analysis enjoyed highly linearity, repeatability, robustness, ruggedness, selectivity, rapidly, and economical to use. The chromatographic system depends on the RP-BDS column (250 mm x 4.6 mm x 5 μm). The mobile phase was prepared by mixing Metha-nol: Phosphate buffer (3:7, v/v) at flow rate 1.0 ml/min with wavelength detection at 254 nm, the temperature at 30° C with injection volume 20 μL. The method revealed that satisfied linearity regression R2 (0.9996) with repeatability (0.94%) with DL and QL; 59.3 ng/ml and 179.8 ng/ml respectively. The method showed successful and satisfying results for Cfx in bulk and pharmaceutical formulations and urine samples at low levels.

Original languageEnglish
Pages (from-to)631-645
Number of pages15
JournalActa Pharmaceutica Sciencia
Volume59
Issue number1
DOIs
Publication statusPublished - 2021
Externally publishedYes

Keywords

  • Cefixime
  • Detection limit
  • Pharmaceuticals
  • Quantitation limit
  • Validation

ASJC Scopus subject areas

  • Pharmaceutical Science

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