Adams E, Schepers R, Gathu L W, Kibaya R, Roets E, Hoogmartens J
Laboratorium voor Farmaceutische Chemie en Analyse van Geneesmiddelen, Faculteit Farmaceutische Wetenschappen, Katholieke Universiteit Leuven, Belgium.
J Pharm Biomed Anal. 1997 Jan;15(4):505-11. doi: 10.1016/s0731-7085(96)01881-x.
The development of a liquid chromatographic essay system for the stability study of a formulation containing polymyxin, gramicidin and neomycin is described. For the determination of each group of antibiotics, poly(styrenedivinylbenzene) is used as the stationary phase. The mobile phase for the determination of polymyxin consists of an aqueous solution containing 7 g l-1 of sodium sulfate, 50 ml l-1 of 1 M phosphoric acid and 160 ml l-1 of acetonitrile. UV detection is performed at 215 nm. An aqueous solution containing 70 g l-1 of sodium sulfate, 1.4 g l-1 of sodium octanesulfonate and 50 ml l-1 of 0.2 M phosphate buffer pH 3.0 is used as the mobile phase for the determination of neomycin. Since neomycin has no UV-absorbing chromophore, pulsed electrochemical detection is chosen to determine neomycin. For each method, the influence of the different chromatographic parameters on the separation, the selectivity towards the other active compounds and the excipients, the repeatability and the linearity were investigated. The stability of the formulation was examined at 0, 6 and 12 months.
描述了一种用于含有多粘菌素、短杆菌肽和新霉素制剂稳定性研究的液相色谱分析系统的开发。对于每组抗生素的测定，使用聚苯乙烯 - 二乙烯基苯作为固定相。测定多粘菌素的流动相由含有7 g l-1硫酸钠、50 ml l-1 1 M磷酸和160 ml l-1乙腈的水溶液组成。在215 nm处进行紫外检测。含有70 g l-1硫酸钠、1.4 g l-1辛烷磺酸钠和50 ml l-1 0.2 M pH 3.0磷酸盐缓冲液的水溶液用作测定新霉素的流动相。由于新霉素没有紫外吸收发色团，因此选择脉冲电化学检测来测定新霉素。对于每种方法，研究了不同色谱参数对分离、对其他活性化合物和辅料的选择性、重复性和线性的影响。在0、6和12个月时检查制剂的稳定性。
