Zalewski Przemysław, Garbacki Piotr, Cielecka-Piontek Judyta, Bednarek-Rajewska Katarzyna, Krause Anna
Acta Pol Pharm. 2015 May-Jun;72(3):423-7.
The stability-indicating LC assay method was developed and validated for quantitative determination of cefozopran hydrochloride (CZH) in the presence of degradation products formed during the forced degradation studies. An isocratic, RP-HPLC method was developed with C-18 (250 mm x 4.6 mm, 5 µm) column and 12 mM ammonium acetate-acetonitrile (92:8, v/v) as a mobile phase. The flow rate of the mobile phase was 1.0 mL/min. Detection wavelength was 260 not and temperature was 30°C. Cefozopran hydrochloride as 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 cefozopran hydrochloride in pharmaceuticals and during kinetic studies.
建立了稳定性指示液相色谱法，并对其进行了验证，用于在强制降解研究过程中形成的降解产物存在下，对盐酸头孢唑肟（CZH）进行定量测定。采用C-18（250 mm×4.6 mm，5 µm）柱，以12 mM醋酸铵-乙腈（92:8，v/v）为流动相，开发了一种等度反相高效液相色谱法。流动相流速为1.0 mL/min。检测波长为260 nm，温度为30℃。与其他头孢菌素一样，盐酸头孢唑肟在水溶液中经历了水解、氧化、光解和热降解等降解胁迫条件。所建立的方法在线性、准确度、精密度、选择性和稳健性方面进行了验证。该方法已成功应用于药品中盐酸头孢唑肟的鉴定和测定以及动力学研究。
Zotero 插件