Song J Z, Chen J, Tian S J, Sun Z P
National Institute for the Control of Pharmaceutical and Biological Products of China, Temple of Heaven, Beijing, People's Republic of China.
J Pharm Biomed Anal. 1999 Nov;21(3):569-76. doi: 10.1016/s0731-7085(99)00158-2.
The development of a capillary zone electrophoresis method with head-column field-amplified sample stacking injection for the determination of formoterol (FMTR) in a low dosage dry syrup form was described. To obtain the highest sensitivity, the sample solution was prepared by high content of organic solvent with the presence of a small amount of H+ (60-100 microM) and the capillary inlet end was dipped in water before electroinjection. This method was fully validated in terms of repeatability (RSDs for migration time, peak area of FMTR and peak area ratio between FMTR and I.S. at 1 microg/ml of FMTR was 0.76, 1.10 and 0.55% respectively), reproducibility (RSDs from different capillaries, analytes, days and instruments were 1.52%, 1.04%, 1.16% and 1.93% respectively), linearity (y = 0.827x - 0.085, r = 0.9993 (n = 6) over the range of 0.25-2.0 microg/ml), limits of quantitation, ruggedness and robustness. The method was applied to the determination of the drug in commercial dry syrup preparation (recovery was 100.9%, RSD = 1.5%, n = 5) and proved to be fast and reliable for the quantitation analysis of FMTR in the pharmaceutical form.
描述了一种采用柱头场放大进样的毛细管区带电泳法测定低剂量干糖浆剂型中的福莫特罗（FMTR）。为获得最高灵敏度，样品溶液用高含量有机溶剂并在存在少量H⁺（60 - 100 microM）的情况下制备，且在电进样前将毛细管入口端浸入水中。该方法在重复性（FMTR浓度为1 microg/ml时，迁移时间、FMTR峰面积以及FMTR与内标物峰面积比的相对标准偏差分别为0.76%、1.10%和0.55%）、重现性（来自不同毛细管、分析物、天数和仪器的相对标准偏差分别为1.52%、1.04%、1.16%和1.93%）、线性（在0.25 - 2.0 microg/ml范围内，y = 0.827x - 0.085，r = 0.9993（n = 6））、定量限、耐用性和稳健性方面得到了充分验证。该方法应用于市售干糖浆制剂中药物的测定（回收率为100.9%，相对标准偏差 = 1.5%，n = 5），并证明对于该药物剂型中FMTR的定量分析快速且可靠。
