Kühn K-D, Weber C, Kreis S, Holzgrabe U
Heraeus Medical GmbH, Philipp-Reis-Str. 8/13, 61273 Wehrheim, Germany.
J Pharm Biomed Anal. 2008 Nov 4;48(3):612-8. doi: 10.1016/j.jpba.2008.05.041. Epub 2008 Jun 18.
The quality control of gentamicin in different antibiotic carriers, using MEKC as stability-indicating method is described. Baseline separations of gentamicin C1, C1a, C2, C2a and C2b and, furthermore the impurities and degradation products garamin (GARA), 2-deoxy-streptamine (DSA) and sisomicin (SISO) were achieved with a background electrolyte containing 20mM deoxycholic acid, 15 mM beta-cyclodextrin and 100mM tetraborate (pH 10.0). After derivatization with o-phthaldialdehyde reagent (OPA), UV detection at 340 nm was possible. The method was validated with respect to selectivity, limit of detection (LOD) and quantification (LOQ) of the impurities, linearity, accuracy, precision and robustness. Evaluation of four different antibiotic carriers stored under stability conditions according to the International Conference on Harmonization (ICH) guidelines and older pharmaceutical formulations disclosed good stability.
描述了使用胶束电动毛细管色谱法（MEKC）作为稳定性指示方法对不同抗生素载体中的庆大霉素进行质量控制。使用含有20 mM脱氧胆酸、15 mMβ-环糊精和100 mM四硼酸盐（pH 10.0）的背景电解质，实现了庆大霉素C1、C1a、C2、C2a和C2b以及杂质和降解产物加拉明（GARA）、2-脱氧链霉胺（DSA）和西索米星（SISO）的基线分离。用邻苯二甲醛试剂（OPA）衍生后，可在340 nm处进行紫外检测。该方法在杂质的选择性、检测限（LOD）和定量限（LOQ）、线性、准确性、精密度和稳健性方面得到了验证。根据国际协调会议（ICH）指南对在稳定性条件下储存的四种不同抗生素载体和旧药物制剂进行评估，结果显示稳定性良好。
