2021
DOI: 10.23893/1307-2080.aps.05906
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Fully investigation of rp- hplc analytical method validation parameters for determination of cefixime traces in the different pharmaceutical dosage forms and urine analysis

Abstract: The IUPAC name of Cfx is (6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2(carboxymethoxyimino)acetyl] amino]-3-ethenyl-8-oxo-5-thia-1-azabicyc- ABSTRACTCefixime (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 e… Show more

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Cited by 16 publications
(39 citation statements)
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“…As a general operating procedure, the para-film was used as a preventive action to avoid the adsorbate evaporation during the adsorption process. All tests were performed at least in triplicates with a relative standard deviation of less than 3 percent to assure the repeatability, robustness, and ruggedness of the implemented adsorption process according to the validation guidelines 32 – 36 . The test after adsorption was filtered through a nylon filter paper 0.45 µm pore size using the Buckner filtration system, then a further filtration was conducted using a syringe filter of 0.2 µm before introduction to the HPLC instrument.…”
Section: Methodsmentioning
confidence: 99%
“…As a general operating procedure, the para-film was used as a preventive action to avoid the adsorbate evaporation during the adsorption process. All tests were performed at least in triplicates with a relative standard deviation of less than 3 percent to assure the repeatability, robustness, and ruggedness of the implemented adsorption process according to the validation guidelines 32 – 36 . The test after adsorption was filtered through a nylon filter paper 0.45 µm pore size using the Buckner filtration system, then a further filtration was conducted using a syringe filter of 0.2 µm before introduction to the HPLC instrument.…”
Section: Methodsmentioning
confidence: 99%
“…To identify the related substances that were produced from the Cfm degradation; individual impurities (A, B, C, E, and F) were injected under the same analysis circumstances according to European Pharmacopoeia 21 , 40 . The resolution between the nearest adjacent peak and the Cfm principle peak should be more than 1.5 according to the guidelines of the analytical method validation protocols 21 , 33 , 41 44 .…”
Section: Methodsmentioning
confidence: 99%
“…The unbound AZM concentration was measured by the previously reported HPLC method [22]. The adsorption performance was repeated for three replicates for all experiments (as standard without ZnONPs and tested with ZnONPs) to assess the robustness of the method repeatability according to quality control and method validation guidelines [23][24][25][26][27]. The results were obtained as the mean of three experimental replicates.…”
Section: Adsorption Of Azm By Znonpsmentioning
confidence: 99%