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胶束电动毛细管色谱法测定药物制剂中孟鲁司特钠的稳定性指示方法

Stability indicating method for sodium montelukast in pharmaceutical preparations by micellar electrokinetic capillary chromatography.

作者信息

Roman J, Malesuik M D, Jablonski A, Steppe M

机构信息

Pharmaceutical Sciences Department, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.

出版信息

Pharmazie. 2010 Sep;65(9):645-9.

Abstract

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.

摘要

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。

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