紫外分光光度法测定间尼索地平的含量

DETERMINATION OF mNISOLDIPINE BY ULTRAVIOLET SPECTROPHOTOMETRY

目的间尼索地平为国家一类新药。为了控制该药的质量，采用了两种紫外分光光度法对其进行含量测定。方法分别采用标准曲线法和标准吸收系数法测定间尼索地平的含量。结果标准曲线法测定间尼索地平的平均回收率和相对标准偏差分别为１００．２％、０．６４％（ｎ＝６）。标准吸收系数法测定间尼索地平的平均回收率和相对标准偏差分别为９９．９６％，０．９３％（ｎ＝６）。结论在间尼索地平的含量测定中，两种方法均简便准确，无显著性差异，可作为间尼索地平质量控制的标准方法。

ObjectiveTo control the quality of m-Nisoldipine,a new antihypertensive drug,two methods were used for determination of m-Nisoldipine in raw material and tablets.MethodsBoth the calibration curve and specific absorptivity were adopted to measure m-Nisoldipine.ResultsIn the method of calibration curve,the average recovery and relative standard deviation were respectively 100.2 %, 0.64 %,and in the method of specific absorptivity,the average recovery and relative standard deviation were respectively 99.96 %, 0.93 %.ConclusionIn the determination of m-Nisoldipine,both methods are accurate and simple without obvious difference,and can be used as standard methods for quality control of m-Nisoldipine.