Concepts for New Rapid Simple HPLC Method for Quantification of Fosfomycin Trometamol in Pharmaceutical Dosage Forms with Direct UV Detection

Abstract

Two different concepts for developing direct HPLC-UV methods for quantifying fosfomycin trometamol were developed without any derivatization and modification of the analyte. In the first concept, without the use of alkylamines as ion-pairs in the mobile phase, by using cyanopropyl CN and a strong anion-exchanger column, we investigated the possibility of their highly polar and anion-exchanging forces and mechanisms to retain, separate and detect trometamol without the help of additional agents or modifiers. In the second concept, the most frequent reversed-phase C18 columns with different characteristics and vendors were tested in combination with different length-based alkylamines with 3–10 C atoms in their chains. In our research, we found that the ion-pairing of fosfomycin with 6–10 C-atom-based alkyl-length of aliphatic chains manifested the most appropriate strength of interactions between alkyl-paired trometamol molecules and octadecylsilane or C18 bonded RP column to achieve optimal retention, selectivity and peak shape on chromatograms, with the possibility for the fine-tuning of elution time. The simplicity of our method concept omits the need for expensive and sophisticated columns like HILIC, C30 graphite carbon, and mixed-mode-based columns for easier retaining, separation, and determination of fosfomycin, and for its quantification purposes, especially in high-throughput analyses in regular quality-control laboratories.

Optimization of LC-MS/MS Analytical Method for Trace Level Quantification of Potential Genotoxic Impurities in Siponimod Pure Drug and Formulations

“…The waters C18 (150 × 4.6mm; 5 μm pore size) column at 30 °C performs best among the other columns studied in terms of resolution, symmetry and hence was selected as appropriate for the study. Literature also confirms that, this column was very efficient for resolution of various compounds and its impurities (Piponski et al 2022;Khalil et al 2023). An appropriate mobile phase was finalized by optimizing different composition of mobile phase including ammonium acetate, acetic acid, aqueous ammonia at various strengths.…”

ICP-MS: a tool for detection and quantitation of fosfomycin residues in cleaning samples of finished product by estimation of phosphorous load

“…Even though its structure does not show chromophoric characteristics, it is reported that fosfomycin can be detected in the lowest UV range (below 190-200 nm). 18 However, it is a strenuous task to conduct analysis with commonly used solvents and buffers in this UV range. Also, inadequate retention in the reverse phase column due to the presence of a highly acidic, ionizable epoxide ring is observed.…”