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对褪黑素制剂及其原料药的含量测定方法进行了研究，建立了反相HPLC定量分析方法，使用YQWC18色谱柱（4．6mmX200mm，10μm），流动相：甲醇：水（60：40），检测波长223nm，采用外标峰高法定量。该方法简便、快速、准确，重视性好（n=1G），RSD=0．3511％，回收率（n=5）100．27％，RSD=0．06079％；检测线性范围20ng～400ng。
The method for the determination of melatonin and its drug substance was studied. A reversed-phase HPLC method was developed for the quantitative determination of melatonin. The mobile phase consisted of methanol: water (60:40), YQWC18 (4.6mm × 200mm, 10μm) Detection wavelength of 223nm, using external standard peak height quantitative. The method was simple, rapid, accurate and highly valued (n = 1G). RSD was 0.3511%. The recovery was 100.27% with RSD = 0.06079%. The linear range was 20ng ~ 400ng.