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Liquid chromatography–tandem mass spectrometry method for the determination of cefuroxime axetil diastereoisomers: application to stability-indicating method

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Abstract

A liquid chromatography–tandem mass spectrometry (LC–MS/MS) method has been executed and validated to quantify cefuroxime axetil in the presence of its degradation products. Cefuroxime axetil and its degradation products were resolved with time programmed gradient elution on Eclipse XDB-C18 column (100 × 4.6 mm, 3.5 µm, Agilent, USA) kept at 40 °C. Under negative ion electrospray ionization, the analyte was quantified and monitored on a triple quadrupole mass spectrometer using multiple reaction monitoring scanning mode. Good results concerning the different validation parameters of the cefuroxime axetil were collected. The linearity was established in the range of 1.0–1000 ng mL−1 and showed an excellent correlation coefficient value (r ≥ 0.999). A comprehensive stress testing of cefuroxime axetil has been implemented according to the International Conference on Harmonization guidelines Q1A (R2).

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Authors and Affiliations

  1. Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Mansoura University, Dakahlia, Egypt

    Mohie M. K. Sharaf El-Din

  2. Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt

    Mohamed W. I. Nassar & Khalid A. M. Attia

  3. Center of Excellence for Preclinical Research in Drug Development, City of Scientific Research and Technological Applications, New Borg El-Arab, Alexandria, 21934, Egypt

    Maha A. El Demellawy

  4. Pharmaceutical & Fermentation Industries Development Center, City of Scientific Research and Technology Applications, New Borg El-Arab, Alexandria, 21934, Egypt

    Mohamed M. Y. Kaddah

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  1. Mohie M. K. Sharaf El-Din
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  2. Mohamed W. I. Nassar
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  3. Khalid A. M. Attia
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Correspondence to Mohamed M. Y. Kaddah.

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Sharaf El-Din, M.M.K., Nassar, M.W.I., Attia, K.A.M. et al. Liquid chromatography–tandem mass spectrometry method for the determination of cefuroxime axetil diastereoisomers: application to stability-indicating method. J IRAN CHEM SOC 18, 2505–2515 (2021). https://doi.org/10.1007/s13738-021-02210-2

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