Development and validation of the stability-indicating LC-UV method for the determination of cefoselis sulphate |
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Authors: | Przemysław Zalewski Judyta Cielecka-Piontek Anna Jelińska |
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Institution: | 1.Department of Pharmaceutical Chemistry, Faculty of Pharmacy,Poznan University of Medical Sciences,Poznań,Poland |
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Abstract: | 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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