Roman J, Malesuik M D, Jablonski A, Steppe M
Pharmaceutical Sciences Department, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.
Pharmazie. 2010 Sep;65(9):645-9.
A simple, reliable micellar electrokinetic chromatography method (MEKC) for the determination of sodium montelukast in coated tablets was developed and validated. Successful results were obtained with 10 mmol L(-1) borate buffer and 30 mmol L-(1) sodium dodecyl sulfate at pH 9.4, injection time of 5.0 s, an applied voltage of 25 kV and a column temperature of 25 degrees C. The detector response for sodium montelukast was linear over the concentration range from 20 to 100 microg mL(-1) (r = 0.9995). The intra and inter-day precision showed suitable results (RSD < 1.46%). The analytical method accuracy was 99.67% (RSD = 1.11%). The limits of detection and quantitation were 0.75 and 2.00 microg mL(-1) respectively. The method demonstrated robustness and showed to be viable for the sodium montelukast determination in pharmaceutical dosage form.
开发并验证了一种用于测定包衣片中孟鲁司特钠的简单、可靠的胶束电动色谱法(MEKC)。在pH 9.4的10 mmol L(-1)硼酸盐缓冲液和30 mmol L-(1)十二烷基硫酸钠中,进样时间为5.0 s,施加电压为25 kV,柱温为25℃时,获得了成功的结果。孟鲁司特钠的检测器响应在20至100 μg mL(-1)的浓度范围内呈线性(r = 0.9995)。日内和日间精密度显示出合适的结果(RSD < 1.46%)。分析方法的准确度为99.67%(RSD = 1.11%)。检测限和定量限分别为0.75和2.00 μg mL(-1)。该方法具有稳健性,对于药物剂型中孟鲁司特钠的测定是可行的。