Abstract

Stability-indicating LC methods were developed and validated for the quantitative determination of doripenem, meropenem and tebipenem in the presence of their degradation products formed during forced degradation studies. Isocratic HPLC and UHPLC separations were performed with a core–shell Kinetex 1.7, 2.6 and 5 µm, all C18, 100A, 100 × 2.1 mm columns and the mobile phase composed of acetonitrile and 12 mmol L−1 ammonium acetate in different ratios. The flow rates of the mobile phase were: 0.5 mL min−1 for 1.7 µm column, and 1.0 mL min−1 for 2.6 and 5 µm ones. Detection wavelength was 298 nm and temperature was set at 30 °C. All analysed drugs were exposed to stress conditions which caused their hydrolysis and thermal degradation. The methods were validated by evaluation of linearity, accuracy, precision, selectivity and robustness. Proposed methods were successfully applied for the determination of investigated antibiotics during kinetic studies in aqueous solutions and in the solid state. The advantages of chromatographic procedures which are based on the use of C18 stationary phases with different particle sizes in the analysis of selected carbapenems were discussed.

Highlights

  • Significant susceptibility of some drugs to degradation requires proper selection of conditions of chromatographic separation

  • Isocratic HPLC and UHPLC separations were performed with a core–shell Kinetex 1.7, 2.6 and 5 μm, all C18, 100A, 100 × 2.1 mm columns and the mobile phase composed of acetonitrile and 12 mmol L−1 ammonium acetate in different ratios

  • Proposed methods were successfully applied for the determination of investigated antibiotics during kinetic studies in aqueous solutions and in the solid state

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Summary

Introduction

Significant susceptibility of some drugs to degradation requires proper selection of conditions of chromatographic separation. The advantages of chromatographic procedures which are based on the use of C18 stationary phases with different particle sizes in the analysis of selected carbapenems were discussed. Carbapenems doripenem (DOR), meropenem (MER) and tebipenem (TEB) were chosen as model drugs, which exhibit a significant instability in aqueous solutions and in the solid state.

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