TY - JOUR
T1 - Fully investigation of rp-hplc analytical method validation parameters for determination of cefixime traces in the different pharmaceutical dosage forms and urine analysis
AU - Al-Hakkani, Mostafa F.
AU - Gouda, Gamal A.
AU - Hassan, Sedky H.A.
AU - Farghaly, Osman A.
AU - Mohamed, Mahmoud M.A.
N1 - Funding Information:
The corresponding author gratefully acknowledges the Academy of Scientific Research & Technology (ASRT), Egypt, Grant No. 6371 under the project Science Up., UP pharma industrial, Al-Esraa pharmaceutical optima industrial, Bio-Med industrial, and Smart pharma for pharmaceuticals for their valuable supports.
Publisher Copyright:
© 2021, İstanbul Medipol University. All rights reserved.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Cefixime
KW - Detection limit
KW - Pharmaceuticals
KW - Quantitation limit
KW - Validation
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U2 - 10.23893/1307-2080.APS.05906
DO - 10.23893/1307-2080.APS.05906
M3 - Article
AN - SCOPUS:85098961358
SN - 1307-2080
VL - 59
SP - 631
EP - 645
JO - Acta Pharmaceutica Sciencia
JF - Acta Pharmaceutica Sciencia
IS - 1
ER -