The Chromatographic Approach to Kinetic Studies of Tebipenem Pivoxil

A validated high-performance liquid chromatography-diode array detector (HPLC-DAD) method for stability studies of tebipenem pivoxil was developed. The separation of tebipenem pivoxil in the presence of main degradation product—tebipenem—was achieved by using a LiChrospher C-18 column (5 µm, 250 × 4...

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Bibliographic Details
Published in:Journal of chromatographic science 2015-02, Vol.53 (2), p.325-330
Main Authors: Cielecka-Piontek, Judyta, Zalewski, Przemysław, Paczkowska, Magdalena
Format: Article
Language:English
Subjects:
Arrays
Carbapenems - analysis
Carbapenems - chemistry
Chromatography
Chromatography, High Pressure Liquid - methods
Degradation
Detectors
Drug Stability
Flow rate
Limit of Detection
Linear Models
Liquids
Metabolites
Relative humidity
Reproducibility of Results
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Summary:A validated high-performance liquid chromatography-diode array detector (HPLC-DAD) method for stability studies of tebipenem pivoxil was developed. The separation of tebipenem pivoxil in the presence of main degradation product—tebipenem—was achieved by using a LiChrospher C-18 column (5 µm, 250 × 4.6 mm) with the mobile phase containing a mixture of 50 mmol L−1 ammonium acetate–acetonitrile–triethylamine (68 : 30 : 2, v/v/v) adjusted to pH 3.5 with concentrated phosphoric acid (V). The column effluent was monitored by a photodiode array detector at 330 nm. The flow rate was 0.8 mL min−1. Tebipenem pivoxil was subjected to degradation in aqueous solutions (acid–base hydrolysis, oxidation) and in the solid state (photolysis, thermolysis at an increased relative humidity and in dry air). The validated HPLC method was successfully applied to investigate the kinetics of conversion of tebipenem pivoxil to tebipenem (main metabolite). The other degradation products of tebipenem pivoxil were also monitored.
ISSN:0021-9665
1945-239X
DOI:10.1093/chromsci/bmu063