Fish B J, Carr G P
J Chromatogr. 1986 Feb 26;353:39-50. doi: 10.1016/s0021-9673(01)87075-8.
A method is described for the determination of the factors in tylosin base and tylosin tartrate as raw materials and in dosage forms. The reversed-phase chromatographic system is compared with other similar systems in terms of selectivity towards the major tylosin factors and an aldol condensation degradation product observed in tylosin injection. Experimental conditions affecting the separation of the components are discussed, together with procedures to demonstrate system validity. It is considered that the methods developed provide appropriate procedures for inclusion in pharmacopoeial monographs for tylosin, tylosin tartrate, tylosin premix, tylosin soluble powder, tylosin tablets and tylosin injection.
本文描述了一种用于测定泰乐菌素碱、泰乐菌素 tartrate 作为原料药以及在剂型中的各因素的方法。将反相色谱系统与其他类似系统在对泰乐菌素主要因素以及在泰乐菌素注射液中观察到的一种羟醛缩合降解产物的选择性方面进行了比较。讨论了影响各组分分离的实验条件以及证明系统有效性的程序。认为所开发的方法为纳入泰乐菌素、泰乐菌素 tartrate、泰乐菌素预混剂、泰乐菌素可溶性粉、泰乐菌素片和泰乐菌素注射液的药典专论提供了合适的程序。
