论文部分内容阅读
目的:采用高效液相色谱法测定匹诺塞林的含量及其有关物质。方法:采用Kromasil C18色谱柱(4.6mm×150mm,5μm);以甲醇-水(用磷酸调pH至3.0)(63∶37)为流动相;流速1.0mL·min-1;检测波长:290nm;柱温:室温;进样量:20μL。结果:高效液相色谱法测定的线性范围为2~200μg.mL-1;相关系数r=1.0000;日内精密度:RSD为0.10%(n=5);日间精密度:RSD为0.14%(n=5)。杂质1、2、4的线性范围为0.05~50μg.mL-1;相关系数r分别为1.0000,1000,0.9999。杂质3的线性范围为0.2~8μg.mL-1;相关系数r=0.9999。结论:本法简便快速、准确、专属性好。
OBJECTIVE: To determine the content of pinoterlin and its related substances by high performance liquid chromatography. Methods: Kromasil C18 column (4.6 mm × 150 mm, 5 μm) was used. The mobile phase consisted of methanol and water (adjusted to pH 3.0 with phosphoric acid) (63:37), the flow rate was 1.0 mL · min -1 and the detection wavelength was 290 nm. Column temperature: room temperature; injection volume: 20μL. Results: The linear range of HPLC was 2 ~ 200μg.mL-1; the correlation coefficient was r = 1.0000; intra-day precision was 0.10% (n = 5); RSD was 0.14% n = 5). The linear range of impurities 1, 2 and 4 was 0.05 ~ 50μg.mL-1, and the correlation coefficients r were 1.0000,1000,0.9999. The linear range of impurity 3 is 0.2 ~ 8μg.mL-1; the correlation coefficient r = 0.9999. Conclusion: This method is simple, fast, accurate and specific.