中藥製劑中摻加Aminitrozole, Metronidazole, Ornidazole及Tinidazole之高效液相層析分析   全文下載

Determination of Aminitrozole, Metronidazole, Ornidazole and Tinidazole Adulterated in Traditional Chinese Medicine by High Performance Liquid Chromatography

本研究利用高效液相層析方法，分析aminitrozole、metronidazole、ornidazole及tinidazole四種西藥成分於中藥製劑中之摻加情況。本法採用C18逆相層析管柱，以pH5.5之0.01M磷酸鹽溶液：乙?（85：15）作等壓沖提。結果顯示，四種西藥成分之檢量線之直線相關係數介於0.9998至0.9999間，顯示良好之線性關係。添加於桂枝茯苓丸之回收率依序為aminitrozole，87.5%；metronidazole，90.0%；ornidazole，86.4%及tinidazole，85.9%，顯示準確性尚可接受。最低檢出濃度介於0.1μg／ml至0.4μg／ml間。同日內之相對標準差為1.5-1.6%，異日間之相對標準差為2.6-5.7%，顯示再現性亦可接受。依此法分析送本局檢驗之中藥丸中摻加tinidazole之情況，其添加回收率為103.9%。結果顯示該中藥丸所含tinidazole之量介於3.1～4.4%之間。所檢測之9粒檢體中每丸tinidazole之含量介於15.3mg至22.0mg之間。

Four antitrichomonal drugs, aminitrozole, metronidazole, omidazole and tinidawle, adulterated in traditional Chinese medicine were assayed simultaneously by high performance liquid chromatography on an ODS column. This chromatographic method was carried out using isocratic elution with 0.01 M phosphate buffer (pH 5.5) and acetonitrile (85:15). Calibration graphs of four adulterants were constructed in the range 0.02- 0.20 mg/ml and their correlation coefficients calculated in the range 0.9998-0.9999. The recoveries of antitrichomonal drugs added to Gui-ChiHu- Lin-Wan were 87.5% for arninitrozole, 90.0% for metronidazole, 86.4% for ornidazole and 85.9% for tinidazole. The relative standard deviations for intraday and interday analyses were 1.5-1.6% and 2.6-5.7% (n=5), respectively. Tinidazole was detected and confirmed by TLC, UV and GC-MS from a herbal black pill that was consigned by The High Court on Sep. 1994. The assay of tinidazole was carried out by the HPLC method mentioned above. The recovery of tinidazole added to the traditional Chinese medicine was 103.9%. The content of tinidazole in the black pill was ranged from 3.1 to 4.4% (15.3-22.0mg in each pill).