Identification,Infrared Absorption á197Sñ
Cell:
1mm.
Solution
Place a volume of Syrup,equivalent to about 200mg of amantadine hydrochloride,in a vessel,dissolve in 0.1Nhydrochloric acid,and filter.Transfer the filtrate to a separator,add 10mLof 0.5Nsodium hydroxide,and extract with 5mLof methylene chloride.Filter the extract through anhydrous sodium sulfate,and rinse the anhydrous sodium sulfate with 2mLof methylene chloride.
Assay
Assay preparation
Pipet 5.0mLof the Syrup into a 250-mLconical flask,and add 45mLof 1.0Nsodium hydroxide and 50.0mLof Internal standard solution.Shake for 60minutes,and collect the hexane layer (Assay preparation).
Procedure
Proceed as directed in the
Assayunder
Amantadine Hydrochloride Capsules.Calculate the quantity,in mg,of C
10H
17N·HCl in the portion of Syrup taken by the formula:
50C(RU/RS),
in which
Cis the concentration,in mg per mL,of
USP Amantadine Hydrochloride RSin the
Standard preparation;and
RUand
RSare the peak response ratios obtained from the
Assay preparationand the
Standard preparation,respectively.