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目的建立高效液相色谱法测定盐酸地芬尼多片的含量与有关物质的方法。方法采用VP-ODSC18色谱柱(4.6mm×250mm,5μm),以0.5%三乙胺溶液(用磷酸调节pH值至4.0)-甲醇(44∶56)为流动相;流速为0.8mL·min-1;检测波长为210nm,柱温:30℃。结果盐酸地芬尼多与有关物质及各降解成分完全分离;盐酸地芬尼多浓度在3.158～63.15mg·L-1内与峰面积呈良好线性关系,r=1.0000(n=7);最低检出限为1ng,最低定量限为3ng;低、中、高3种浓度的回收率(n=3)分别为100.4%(RSD=0.4%),99.5%(RSD=0.8%),99.8%(RSD=0.4%)。结论该方法操作简便、快速、准确,灵敏度高,可用于盐酸地芬尼多片含量及有关物质的测定。
Objective To establish a HPLC method for the determination of dipheniri hydrochloride tablets and related substances. Methods The mobile phase consisted of VP-ODSC18 column (4.6 mm × 250 mm, 5 μm), 0.5% triethylamine (adjusted to pH 4.0 with phosphoric acid) -methanol (44:56) 1; detection wavelength was 210nm, column temperature: 30 ℃. Results The concentration of phenylephrine hydrochloride was completely separated from the related substances and the components of degradation. The concentration of phenylephrine hydrochloride in the range of 3.158 ~ 63.15 mg · L-1 showed a good linear relationship with the peak area, r = 1.0000 (n = 7) (RSD = 0.4%), 99.5% (RSD = 0.8%), 99.8% (RSD = 0.8%), and the detection limit was 1ng with the lowest limit of quantification being 3ng. (RSD = 0.4%). Conclusion The method is simple, rapid, accurate and sensitive. It can be used to determine the content of phenylephrine hydrochloride and its related substances.