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Stability-indicating derivative spectrophotometry method for the determination of biapenem in the presence of its degradation products

100%
Cielecka-Piontek J., Lunzer A., Jelińska A.
Open Chemistry
|
2011
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vol. 9
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issue 1
35-40
EN
A first-derivative UV spectrophotometric method, with or without the subtraction technique, was developed for the determination of biapenem in pharmaceutical dosage form in the presence of its degradation products. The method was based on the measurement of first-derivative amplitudes at zero crossing point (λ = 312 nm) and the peak-to-zero technique and validated with regard to linearity, limits of detection and quantitation, selectivity and precision. The observed rate constants for the degradation of biapenem were comparable to those obtained in the stability-indicating HPLC method. [...]
2
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Development and validation of the stability-indicating LC-UV method for the determination of cefoselis sulphate

100%
Zalewski P., Cielecka-Piontek J., Jelińska A.
Open Chemistry
|
2012
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vol. 10
|
issue 1
121-126
EN
The stability-indicating LC assay method was developed and validated for quantitative determination of cefoselis sulphate in the presence of degradation products formed during the forced degradation studies. An isocratic, RP-HPLC method was developed with C-18 (250 × 4.6 mm, 5 µm) column and 12 mM ammonium acetate-acetonitrile (95:5 V/V) as a mobile phase. The flow rate of the mobile phase was 1.0 mL min−1. Detection wavelength was 260 nm and temperature was 30°C. Cefoselis similarly to other cephalosporins was subjected to stress conditions of degradation in aqueous solutions including hydrolysis, oxidation, photolysis and thermal degradation. The developed method was validated with regard to linearity, accuracy, precision, selectivity and robustness. The method was applied successfully for identification and determination of cefoselis sulphate in pharmaceuticals and during kinetic studies.
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STABILITY STUDIES OF CEFTIOFUR SODIUM IN AQUEOUS SOLUTIONS AND IN THE SOLID PHASE

76%
Dołhań A., Sobczak A., Muszalska I., Medenecka B., Garbacki P., Tomczak S., Jelińska A.
Acta Poloniae Pharmaceutica - Drug Research
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2018
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vol. 75
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issue 6
1279-1286
EN
Ceftiofur sodium (CFT), a third-generation cephalosporin for parenteral use, is commonly used in veterinary medicine against aerobic Gram-positive and Gram-negative bacteria as well as certain anaerobes. Its broad spectrum of activity and resistance to beta-lactamases result from the presence of methoxyimino and aminothiazole moieties at C-7 in the cephalosporin structure. The aim of this study was a comprehensive evaluation of the stability of CFT in the solid phase and in aqueous solutions. A fast and sensitive HPLC isocratic method was used for the determination of CFT degradation in the solid phase and in aqueous solutions. CFT degradation occurred according to a first-order reaction depending on the substrate concentration. The kinetic and thermodynamic parameters of CFT degradation in the solid phase were calculated. General acid-base hydrolysis of CFT was not observed in the solutions of hydrochloric acid, sodium hydroxide, phosphate (pH 5.84 – 7.25), acetate (pH 3.65 – 5.48) and borate (pH 7.49 – 10.07) buffers. CFT was the most stable in the pH range 2 – 6. The susceptibility of CFT to degradation under the influence of stress factors (pH, temperature, buffer components concentration, relative air humidity) should be considered in terms of storage conditions and the preparation of the product for administration.
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