HPLC法测定硝苯地平片含量的方法学研究

目的 建立了一种HPLC 方法用于硝苯地平片的含量测定。方法 采用ODS 柱,以甲醇-水(60 ∶40)为流动相,流速为0.8 ml·min^-1,检测波长为235nm 。结果 硝苯地平的线性范围为0.020 ~ 0.200 g·L^-1;高、中、低3 个浓度的平均回收率分别为99.6%,98.9%,100.4%;RSD 分别为0.42%,0.54%,0.35%(n=5)。结论 本法专属性强,灵敏度高,结果准确,快速简便。

Study on a HPLC method of determination of nifedipine content

AIM: To establish a HPLC method to determine nifedopine the content and uniformity of nifedopine tablet.METHODS: HPLC condition was set as ODS column,flow phase:methanol-water(60 ∶40),flow rate:0.8 ml·min^-1,and detection wavelength:235nm.RESULTS: The nifedopine linear range was 0.020-0.200 g ·L^-1 in this method.The average recovery rates were 99.6%,98.9%,and 100.4% in high,normal and low concentrations,respectively.The corresponding values of RSD were 0.42%,0.54% and 0.35%(n=5).CONCLUSION: This HPLC method shows a high specificity and sensitivity,and is accurate,simple and rapid in performance.