胶束电动毛细管色谱法分析头孢羟氨苄：方法建立与验证
Analysis of cefadroxil by micellar electrokinetic capillary chromatography: development and validation.
作者信息
Li Y M, Vanderghinste D, Pecanac D, Van Schepdael A, Roets E, Hoogmartens J
机构信息
Laboratorium voor Farmaceutische Chemie en Analyse van Geneesmiddelen, Faculteit Farmaceutische Wetenschappen, K.U. Leuven, Belgium.
出版信息
Electrophoresis. 1998 Nov;19(16-17):2890-4. doi: 10.1002/elps.1150191615.
A method is developed and validated for analysis of the antibiotic cefadroxil using micellar electrokinetic capillary chromatography. It permits cefadroxil to be completely separated from ten of its known related substances within 15 min (including the washing procedure). The separation is performed in an acetate buffer (50 mM, pH 5.25) containing sodium dodecyl sulfate (SDS; 110 mM). The fused-silica capillary was 44 cm long (36 cm effective length), 50 microm ID; the voltage, 18 kV; temperature, 15 degrees C; and the detection wavelength; 254 nm. The influence of the type of buffer, buffer pH and concentration, and of the SDS concentration was investigated. The robustness of the method was examined by means of a full-fraction factorial design. The parameters for validation such as linearity, precision, limit of detection and limit of quantitation are also reported.
开发并验证了一种采用胶束电动毛细管色谱法分析抗生素头孢羟氨苄的方法。该方法可使头孢羟氨苄在15分钟内（包括清洗过程）与十种已知相关物质完全分离。分离在含有十二烷基硫酸钠（SDS；110 mM）的醋酸盐缓冲液（50 mM，pH 5.25）中进行。熔融石英毛细管长44 cm（有效长度36 cm），内径50 µm；电压18 kV；温度15℃；检测波长254 nm。研究了缓冲液类型、缓冲液pH值和浓度以及SDS浓度的影响。通过全因子析因设计检验了该方法的稳健性。还报告了线性、精密度、检测限和定量限等验证参数。
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