Marchesini A F, Williner M R, Mantovani V E, Robles J C, Goicoechea H C
Laboratorio de Control de Calidad de Medicamentos, Departamento de Química, Facultad de Bioquímica y Ciencias Biológicas, Universidad Nacional del Litoral, Ciudad Universitaria, CC 242, S3000 Santa Fe, Argentina.
J Pharm Biomed Anal. 2003 Feb 5;31(1):39-46. doi: 10.1016/s0731-7085(02)00600-3.
A capillary zone electrophoresis (CZE) method has been developed to separate and quantitate naphazoline (NAPH), dyphenhydramine (DIP) and phenylephrine (PHE) in nasal solutions. Samples were diluted 1:25 in ultrapure water and injected at the anodic end. A central composite design has been used to optimise the experimental conditions for a complete and fast separation of the active ingredients studied. Critical parameters such as voltage, pH and buffer concentration have been studied to evaluate how they affect responses such as resolution and migration times. Separation was performed on a silica capillary with 75 microm I.D. and 70 cm total length at an applied voltage of 17.7 kV with a phosphate run buffer of pH 3.72 and 0.063 mol l(-1). Calibration curves were prepared for NAPH, DIP and PHE. For each analyte, the correlation coefficients were >0.999 (n=15). The RSD% of six replicate injections for each analyte were reasonably good. The method was applied to the quantitation of the three components in a commercial dosage form. The proposed method has the advantage of needing a very simple sample pretreatment and being faster than a typical HPLC chromatographic method.
已开发出一种毛细管区带电泳(CZE)方法,用于分离和定量鼻用溶液中的萘甲唑啉(NAPH)、苯海拉明(DIP)和去氧肾上腺素(PHE)。样品在超纯水中按1:25稀释,并在阳极端进样。采用中心复合设计优化实验条件,以实现所研究活性成分的完全快速分离。研究了诸如电压、pH值和缓冲液浓度等关键参数,以评估它们如何影响诸如分离度和迁移时间等响应。在内径为75微米、总长度为70厘米的硅胶毛细管上进行分离,施加电压为17.7 kV,运行缓冲液为pH 3.72的磷酸盐缓冲液,浓度为0.063 mol l(-1)。制备了NAPH、DIP和PHE的校准曲线。对于每种分析物,相关系数均>0.999(n = 15)。每种分析物六次重复进样的相对标准偏差(RSD%)相当良好。该方法应用于商业剂型中三种成分的定量分析。所提出的方法具有样品预处理非常简单且比典型的高效液相色谱(HPLC)方法更快的优点。