Poirier M A, Curran N M, McErlane K M, Lovering E G
J Pharm Sci. 1979 Sep;68(9):1124-7. doi: 10.1002/jps.2600680917.
Two lots of trihexyphenidyl hydrochloride raw material, one lot of elixir, and 10 lots of tablets were examined for impurities by TLC. Impurities found were 1-phenyl-2-propenone, 3-piperidinopropiophenone, and 3-aminopropiophenone. Not all impurities were present in all lots, and none exceeded 1.9% of the label drug claim. Impurities were identified by mass spectrometry and by comparison of TLC Rf values and GLC retention times to those of synthesized specimens of the impurities.
对两批盐酸苯海索原料药、一批酏剂和十批片剂进行了薄层色谱法杂质检测。检测到的杂质有1-苯基-2-丙烯酮、3-哌啶基丙酰苯和3-氨基丙酰苯。并非所有批次都含有所有杂质，且没有一种杂质超过标示药物含量的1.9%。通过质谱法以及将薄层色谱比移值和气相色谱保留时间与杂质合成样品的比移值和保留时间进行比较来鉴定杂质。
