Packaging and storage—
Preserve in tight containers,protected from light.
Identification—
Transfer a volume of Elixir,equivalent to about 10mg of fluphenazine hydrochloride,to a separator,and to a second separator transfer 10mg of
USP Fluphenazine Hydrochloride RS.To each separator add 20mLof 6Nsodium hydroxide,and extract each mixture with 20mLof isooctane.Evaporate the isooctane solutions to dryness,and proceed as directed in the
Identificationtest under
Fluphenazine Hydrochloride Tablets,beginning with “dissolve the residues in 0.5-mLportions.”
Alcohol content á611ñ:
not less than 90.0%and not more than 110.0%of the labeled amount,the labeled amount being not more than 15.0%of C
2H
5OH.
Assay—
Diluent solution,Mobile phase,Standard preparation,and Chromatographic system—
Proceed as directed in the
Assayunder
Fluphenazine Hydrochloride.
Assay preparation—
Using a “to contain”pipet transfer a volume of Elixir,equivalent to about 6mg of fluphenazine hydrochloride,to a 100-mLvolumetric flask.Rinse the pipet with Diluent solutionto complete the transfer,dilute with Diluent solutionto volume,and mix.Filter,discarding the first 5mLof the filtrate.
Procedure—
Separately inject equal volumes (about 25µL)of the
Standard preparationand the
Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of fluphenazine hydrochloride (C
22H
26F
3N
3OS·2HCl)in each mLof the Elixir taken by the formula:
100(C/V)(rU/rS),
in which
Cis the concentration,in mg per mL,of
USP Fluphenazine Hydrochloride RSin the
Standard preparation;Vis the volume,in mL,of Elixir taken;and
rUand
rSare the peak responses obtained from the
Assay preparationand the
Standard preparation,respectively.