ACTA Pharmaceutica Sciencia 2021 , Vol 59 , Num 1
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 1-2 Gamal. A. Gouda 1 Sedky H.A. Hassan 3 Osman A. Farghaly 1 Mahmoud M.A. Mohamed 2
1 Department of Chemistry, Faculty of Science, Al-Azhar University, Assiut Branch, 71524, Assiut, Egypt
2 Department of Chemistry, Faculty of Science, New Valley University, El-Kharja 72511, Egypt
3 Department of Botany & Microbiology, Faculty of Science, New Valley University, El-Kharja 72511, Egypt
DOI : 10.23893/1307-2080.APS.05906 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 ?m). The mobile phase was prepared by mixing Methanol: 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 ?L. 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. Keywords : Validation, Pharmaceuticals, Cefixime, Detection limit, Quantitation limit

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