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Fluphenazine Hydrochloride Elixir
»Fluphenazine Hydrochloride Elixir contains not less than 90.0percent and not more than 110.0percent of the labeled amount of fluphenazine hydrochloride (C22H26F3N3OS·2HCl).
Packaging and storage—
Preserve in tight containers,protected from light.
USP Reference standards á11ñ—
USP Fluphenazine Hydrochloride RS.
NOTE—Throughout the following procedures,protect test or assay specimens,the USP Reference Standard,and solutions containing them,by conducting the procedures without delay,under subdued light,or using low-actinic glassware.
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.”
Uniformity of dosage units á905ñ—
FOR ELIXIR PACKAGED IN SINGLE-UNIT CONTAINERS:
meets the requirements.
Deliverable volume á698ñ—
FOR ELIXIR PACKAGED IN MULTIPLE-UNIT CONTAINERS:
meets the requirements.
pHá791ñ:
between 5.3and 5.8.
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 C2H5OH.
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 (C22H26F3N3OS·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.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 860
Pharmacopeial Forum:Volume No.29(6)Page 1888
Phone Number:1-301-816-8330
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