Abstract
The stability-indicating LC assay method was developed and validated for quantitative determination of cefcapene pivoxil in the presence of degradation products formed during forced degradation studies. An isocratic RP-HPLC method was developed with a Lichrospher RP-18 (250 mm × 4.6 mm, 5 μm) column and the mobile phase composed of 45 volumes of acetonitrile and 55 volumes of mixture composed of citric acid 10 mmol L−1 and potassium chloride 18 mmol L−1. The flow rate of the mobile phase was 1 mL min−1. Detection wavelength was 270 nm and temperature was 30 °C. Cefcapene pivoxil, similar to other cephalosporins, was subjected to stress conditions of degradation in aqueous solutions including hydrolysis, oxidation, and thermal degradation. The method was validated with regard to linearity, accuracy, precision, selectivity, and robustness. The method was applied successfully for the determination of cefcapene pivoxil during kinetic studies in aqueous solutions (pH and thermal degradation) and in solid state (oxidative, thermal, and radiolytic degradation).
Highlights
Cefcapene pivoxil is a new, oral, third-generation cephalosporin
An isocratic RPHPLC method was developed with a Lichrospher RP-18 (250 mm 9 4.6 mm, 5 lm) column and the mobile phase composed of 45 volumes of acetonitrile and 55 volumes of mixture composed of citric acid 10 mmol L-1 and potassium chloride 18 mmol L-1
The antibacterial activity of cephalosporins is attributed to their b-lactam moieties, which are very susceptible to chemical degradation
Summary
Cefcapene pivoxil is a new, oral, third-generation cephalosporin It has a broad spectrum of antibacterial activity against Gram-positive and Gram-negative bacteria, including Staphylococcus aureus [1]. Cefcapene pivoxil contains a carbamoyloxymethyl group at the C3 position, determining its antibacterial activity against Staphylococcus aureus. It was originally created by Shionogi & Co., Ltd. and launched as Flomox in 1997. The antibacterial activity of cephalosporins is attributed to their b-lactam moieties, which are very susceptible to chemical degradation. Most side effects of b-lactams are caused by their degradation products that hinder the development of analytical methods for the determination of cephalosporins. The stress tests are required to establish the effect of temperature and humidity in the solid state, the impact of temperature, light, oxidizing agent, pH, buffer, and infusion fluids in solutions and the influence of biochemical processes on the formation of metabolites [14]
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