中藥製劑摻加Nifedipine之高效液相層析定量方法之應用

Quantitative Analysis of Nifedipine Adulterated in Traditional Chinese Medicine by HPLC

本研究探討中藥粉中所摻加之西藥，經薄層層析法、紫外光吸光度法及氣相層析質譜儀等確認試驗，結果檢出nifedipine西藥成分，繼以高效液相層析儀測定其nifedipine之含量，採用C18逆相層析管柱，以水：甲醇：乙腈（55:36:9）作沖提液分析。Nifedipine之檢量線回歸方程式為 Y=58.38X—0.20（r=O. 9999），顯示良好之線性關係；同日間及異日間之相對標準偏差分別為0.9%及1.4%（n=5），顯示再現性佳；添加回收率為97.0%（n=3），顯示準確性佳，可用於中藥摻加nifedipine西藥成分之分析。檢體中所含nifedipine之含量百分比為1.21%（n=3），即每公克檢體粉末中含nifedipine 12.1毫克。

In this study, nifedipine was detected and confirmed from one kind of traditional Chinese medicine by TLC, UV and GC-MS. Nifedipine in the sample was assayed by high performance liquid chromatography on a Cosmosil 5C18-AR column by isocratic elution with water-methanol-acetonitrile (55:36:9) as the mobile phase at flow-rate of 1.0 ml/min, with detection at 254 nm. The linear calibration range was 0.02-0.20 mg/ml (r=0 .9999) and recovery was 97.0% (n=3). The relative standard deviations for intraday and interday analysis were 0.9% and 1.4% (n=5), respectively. The content of nifedipine in the sample was 1.21% (n=3).