Shafaati A, Clark B J
Pharmaceutical Chemistry, School of Pharmacy, University of Bradford, UK.
J Pharm Biomed Anal. 1996 Aug;14(11):1547-54. doi: 10.1016/0731-7085(96)01772-4.
The development of a capillary zone electrophoresis method for determination of the drug atenolol in the presence of its related substances in bulk and in a tablet dosage form is described. The method was fully validated in terms of repeatability (RSDs for migration time and peak area of atenolol at 0.05 mg ml-1 were 0.25% and 0.52%, n = 10, respectively), reproducibility (RSD of peak area 0.84%, n = 5), linearity at two ranges of atenolol concentration, limits of detection and quantitation, ruggedness and robustness. The method was applied to the determination of the drug in a commercial tablet preparation (recovery 99.4%, m/m). The method proved to be fast and reliable for the quantitative analysis of atenolol in the presence of its related substances in bulk and pharmaceutical forms.
本文描述了一种毛细管区带电泳法的开发，用于在原料药及其片剂剂型中存在相关物质的情况下测定药物阿替洛尔。该方法在重复性（0.05 mg ml-1阿替洛尔迁移时间和峰面积的相对标准偏差分别为0.25%和0.52%，n = 10）、重现性（峰面积相对标准偏差为0.84%，n = 5）、阿替洛尔两个浓度范围的线性、检测限和定量限、耐用性和稳健性方面进行了全面验证。该方法应用于市售片剂制剂中药物的测定（回收率99.4%，m/m）。事实证明，该方法对于在原料药和药物剂型中存在相关物质的情况下阿替洛尔的定量分析快速且可靠。
