RP-HPLC法同时测定辣椒碱透皮贴剂中4种生物碱类成分的含量

Simultaneous determination of the contents of four alkaloids in capsaicin transdermal patches by RP-HPLC

目的建立RP-HPLC法同时测定辣椒碱透皮贴剂中辣椒碱、二氢辣椒碱、降二氢辣椒碱和高二氢辣椒碱4种生物碱类成分含量。方法采用Kromasil C18(250 mm×4.60 mm,5μm)柱,以乙腈-水(体积比为42∶58)为流动相,流速为1.0 mL·min-1,柱温为40℃,检测波长为280 nm。结果 4种生物碱类成分的色谱峰与邻近色谱峰均能良好的分离,辣椒碱和二氢辣椒碱的质量浓度分别在2.65~79.50 mg·L-1(r=0.999 7)、1.08~64.80 mg·L-1(r=0.999 9)内与峰面积呈良好的线性关系,平均回收率分别为100.2%(RSD=1.5%)、99.5%(RSD=0.7%)。结论该方法可用于辣椒碱透皮贴剂的质量控制。

Objective To establish an RP-HPLC method for the simultaneous determination of capsaicin,dishydrocapsaicin,nordihydrocapsaicin and homodihydrocapsaicin in capsaicin transdermal patches.Methods The HPLC separation was performed on a Kromasil C18(250 mm×4.60 mm,5 μm) column with acetonitrile-water(V∶V=42∶58) as the mobile phase at a flow rate of 1.0 mL·min-1.The column temperature was 40 ℃ and the detection wavelength was 280 nm.Results The chromatographic peaks of the four alkaloids were well separated from the neighboring chromatographic peaks.The mass concentration of capsaicin and dishydrocapsaicin showed good linearity with peak area in the range of 2.65-79.50 mg·L-1(r=0.999 7) and 1.08-64.80 mg·L-1(r=0.999 9),respectively.The average recoveries were 100.2%(RSD=1.5%) and 99.5%(RSD=0.7%),respectively.Conclusion This method can be used for quality control of capsaicin transdermal patches.