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建立寡肽LT58含量测定和有关物质检查的方法。采用Diamonsil C_(18)(4.6mm×250mmm,5 μm)色谱柱;以0.1moL/L磷酸二氢钠(用稀磷酸调节pH至2.96)-甲醇-乙腈(75:15:10)为流动相;柱温为40℃;流速为1.0mL/min;检测波长为210nm。在该色谱条件下,LT58与有关物质能够得到很好的分离,分离度大于1.5,理论板数按LT58计大于5000;LT58浓度在40～160μg/mL范围内与峰面积呈良好的线性关系(r=0.9998);重复性试验RSD为0.8%(n=6);定量限和检测限分别为16ng和8ng。该方法专属性好,精密度、稳定性符合要求,方法可靠,可用于LT58的含量测定和有关物质检查。
To establish oligopeptide LT58 content determination and related substances inspection methods. The mobile phase consisted of Diamonsil C_ (18) (4.6 mm × 250 mmm, 5 μm) column with 0.1 mol / L sodium dihydrogen phosphate (pH adjusted to 2.96 with dilute phosphoric acid) and methanol-acetonitrile ; Column temperature was 40 ℃; flow rate was 1.0mL / min; detection wavelength was 210nm. Under the chromatographic conditions, LT58 and related substances can be well separated, the resolution is greater than 1.5, the number of theoretical plates is greater than 5000 according to LT58; LT58 concentration in the range of 40 ~ 160μg / mL showed a good linear relationship with the peak area ( r = 0.9998); RSD of repeatability test was 0.8% (n = 6); the limits of quantitation and detection were 16ng and 8ng, respectively. The method has the advantages of good specificity, precision and stability, and the method is reliable and can be used for the content determination of LT58 and related material inspection.