HPLC法测定左炔诺孕酮片中主药的含量

目的:建立以高效液相色谱(HPLC)法测定左炔诺孕酮片中主药含量的方法。方法:色谱柱为Agilent Extend C18,流动相为水-乙腈-甲醇(55∶45∶5),流速为1.0mL·min-1,柱温为30℃,检测波长为240nm,以外标法进行测定。结果:左炔诺孕酮检测浓度线性范围为3.5～55.6μg·mL-1(r=0.9996),低、中、高3个浓度的平均回收率分别为100.8%、99.7%、98.8%,RSD分别为0.97%、0.92%、0.91%。结论:该方法简便、准确、可靠,适用于左炔诺孕酮片中主药的含量测定。

Content Determination of Main Component in Levonorgestrel Tablets by HPLC

OBJECTIVE： To determine the content of main component in levonorgestrel tablets by HPLC. METHODS： Agilent Extend C18 column was adopted with mobile phase consisted of water-acetonitrile-methanol （55 ∶ 45 ∶ 5） at the flow rate of 1.0 mL·min^-1. The column temperature was 30 ℃ and detection wavelength was 240 nm. The external standard method was used. RESULTS： The linear range of levonorgestrel was 3.5～55.6 μg·mL-1 （r=0.999 6）. The average recoveries of low, middle and high concentrations were 100.8% （RSD=0.97%）, 99.7% （RSD=0.92%） and 98.8% （RSD=0.91%）. CONCLUSION： The method is simple, accurate, reliable and applicable for the content determination of main component in levonorgestrel tablets.