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

Literature Information

Publication Date 2023-11-03
DOI 10.1039/D3JA00247K
Impact Factor 4.023
Authors

Anirban Roy Chowdhury, Sujal Shah, Rahul Y. Kapse, Tushar Mehta, Amit Mukharya


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Abstract

Due to the significance of health risk factors to patients and the requirements imposed by regulatory authorities, the development of a reliable cleaning assessment method holds great importance in the pharmaceutical industry. Reliable, accurate and sensitive analytical techniques are always the need of the hour to establish any cleaning assessment method. Inductively coupled plasma mass spectrometry (ICP-MS) has been acclaimed for its accuracy and sensitivity to detect and analyse trace level elemental toxic metallic impurities. The exploration of using analytical tools to estimate a non-metallic fraction of an organic compound is not very common, especially in cleaning method assessment. This study details using elemental phosphorus in an organic compound as an indirect approach for trace-level analysis in equipment cleaning validation samples. The aim was to determine and quantify trace levels of fosfomycin residue. An analytical method to analyse equipment cleaning samples at a trace level for a fosfomycin tromethamine finished product has not been reported to date. Due to its uniqueness in its structural (non-chromophoric) and physicochemical (acidic) properties, it was a challenging task to develop a sensitive, robust, and rugged cleaning assessment method at a trace level concentration using conventional chromatographic techniques. In order to accomplish this, phosphorus-based quantification using an ICP-MS technique was explored in a rare application. The developed method is benign to the environment, saves time, and is cost effective compared to conventional chromatographic and hyphenated techniques. The developed analytical method was validated as per the principles of ICH guidelines, applicable for the trace-level analysis of equipment cleaning samples. Although the application is specific, the guiding concept can be explored towards analysing other non-chromophoric molecules by optimizing the sample preparation and instrument parameters of the method, e.g., glyphosate (an antibiotic), cisplatin (an anticancer drug), bilanafos (a herbicide), and phosphinothricin (a metabolite of bilanafos).

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Source Journal

Journal of Analytical Atomic Spectrometry

Journal of Analytical Atomic Spectrometry
CiteScore: 6.2
Self-citation Rate: 25.8%
Articles per Year: 254

The Journal of Analytical Atomic Spectrometry (JAAS) is the central journal for publishing innovative research on fundamentals, instrumentation, and methods in the determination, speciation and isotopic analysis of (trace) elements within all fields of application. This includes, but is not restricted to, the most recent progress, developments and achievements in all forms of atomic and elemental detection, isotope ratio determination, molecular analysis, plasma-based analysis and X-ray techniques. The journal welcomes full papers, communications, technical notes, critical and tutorial review articles, editorials, and comments, in addition to the Atomic Spectrometry Updates (ASU) literature reviews that are prepared by an expert panel. Submissions are welcome in the following areas, but note this list reflects the current scope and authors are strongly encouraged to contact the Editorial team if they believe that their work offers potentially new and emerging research relevant to the journal remit: Fundamental studies in the following. New and existing sources for atomic emission, absorption, fluorescence and mass spectrometry and those that provide both atomic and molecular information Sample introduction techniques for solids, liquids, gases Improvements in sensitivity, selectivity, precision, accuracy and/or robustness Isotope ratio measurements, including techniques for improving precision and mass bias correction Single channel and multichannel simultaneous detection systems Chemometrics, statistics, calibration techniques and internal standardisation Theoretical and numerical modelling of fundamental processes related to all of the above methodologies Novel or improved methodologies in areas of application including, but not limited to the following. Biosciences, including elemental, speciation and isotopic analysis in biological systems, immunoassays based on metal-labeled antibodies, bio-imaging, and nanoparticle toxicology Geochemistry Environmental science Materials science, including engineered nanoparticles and quantum dots Metrology, including reference materials Forensic analysis Food and agricultural sciences Energy Archaeometry Molecular analysis. Molecular sources for elemental and isotopic analysis Atomic sources for molecular analysis Atomic and molecular techniques simultaneously used for complementary chemical information All contributions are judged on originality and quality of scientific content, and appropriateness of length to content of new science.

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