论文部分内容阅读
目的:建立HPLC法测定艾塞那肽的有关物质。方法:采用Phenomenex Luna C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相A为0.05 mol·L~(-1)磷酸二氢钾溶液(10%氢氧化钾溶液调节pH至5.0),流动相B为乙腈,梯度洗脱,流速1.0 ml·min~(-1);柱温30℃;检测波长215 nm。结果:艾塞那肽与其降解产物分离良好,其最低检出限为13.6 ng,在0.02～1.00 mg·ml~(-1)范围内,艾塞那肽浓度与峰面积呈良好的线性关系(r=0.999 9)。结论:该法能灵敏、有效地进行有关物质检测。
Objective: To establish a HPLC method for the determination of exenatide related substances. METHODS: Phenomenex Luna C 18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase A was 0.05 mol·L -1 potassium dihydrogen phosphate solution (10% potassium hydroxide solution was adjusted to pH 5.0 ). The mobile phase B was acetonitrile gradient elution at a flow rate of 1.0 ml · min -1. The column temperature was 30 ℃ and the detection wavelength was 215 nm. Results: The separation of exenatide and its degradation product was good with a minimum detection limit of 13.6 ng. Exenatide showed a good linear relationship with the peak area in the range of 0.02 ~ 1.00 mg · ml ~ (-1) r = 0.999 9). Conclusion: The method can sensitively and effectively detect the related substances.