高效液相色谱法测定酒石酸泰乐菌素有关物质的研究

Determination of Tylosin Tartrate Related Substances by HPLC

关键词:  高效液相色谱法  酒石酸泰乐菌素  梯度洗脱  有关物质

Key words:  HPLC  tylosin tartrate  gradient elution  relevance substance

摘要:

依据欧洲药典讨论稿中酒石酸泰乐菌素有关物质的检测方法，在280 nm波长处，以pH 5.5的磷酸盐缓冲溶液-乙腈-水（10∶27.5∶62.5，V/V)为A流动相，以pH 5.5的磷酸盐缓冲溶液-水-乙腈（10∶40∶50，V/V)为B流动相进行梯度洗脱，并对专属性、准确度、精密度、检测限和定量限、线性和范围、耐用性、及溶液稳定性进行考察。结果显示，杂质A、N、O、R、S峰峰面积与其对应浓度呈线性关系，其相关系数r均大于0.999，各项考察指标均符合要求。结果证明该分析方法能科学、合理的分析、控制酒石酸泰乐菌素有关物质，可以持续、准确地反映酒石酸泰乐菌素的特性。

Abstract:

The determination method of tylosin tartrate related substances from EP discussion draft, At the wavelength of 280 nm, pH 5.5 phosphate buffer solution-acetonitrile-water(10∶27.5∶62.5, V/V) as the mobile phase A, pH 5.5 phosphate buffer solution-water-acetonitrile (10∶40∶50, V/V) as the mobile phase B gradient elution, and the specificity,accuracy, precision, limit of detection and limit of quantification, linearity and range, durability,and solution stability was investigated. The results showed that the impurity A, N, O, R, S peak area and the corresponding concentration showed a linear relationship, the correlation coefficient r was greater than 0.999, the indicators are in line with inspection requirements. It was demonstrated that the method can scientific, reasonable analysis, control of tylosin tartrate related substances, It can be sustained, accurately reflect the characteristics of tylosin tartrate.