Fluphenazine Hydrochloride Elixir
» Fluphenazine Hydrochloride Elixir contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of fluphenazine hydrochloride (C22H26F3N3OS·2HCl).
Packaging and storage— Preserve in tight containers, protected from light.
USP Reference standards 11
USP Fluphenazine Hydrochloride RS Click to View Structure
[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 10 mg of fluphenazine hydrochloride, to a separator, and to a second separator transfer 10 mg of USP Fluphenazine Hydrochloride RS. To each separator add 20 mL of 6 N sodium hydroxide, and extract each mixture with 20 mL of isooctane. Evaporate the isooctane solutions to dryness, and proceed as directed in the Identification test under Fluphenazine Hydrochloride Tablets, beginning with “dissolve the residues in 0.5-mL portions.”
Uniformity of dosage units 905
for elixir packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for elixir packaged in multiple-unit containers: meets the requirements.
pH 791: between 5.3 and 5.8.
Alcohol content 611: 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.
Diluent solution, Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Fluphenazine Hydrochloride.
Assay preparation— Using a “to contain” pipet transfer a volume of Elixir, equivalent to about 6 mg of fluphenazine hydrochloride, to a 100-mL volumetric flask. Rinse the pipet with Diluent solution to complete the transfer, dilute with Diluent solution to volume, and mix. Filter, discarding the first 5 mL of the filtrate.
Procedure— Separately inject equal volumes (about 25 µL) of the Standard preparation and the Assay preparation into 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 mL of the Elixir taken by the formula:
100(C/V)(rU / rS)
in which C is the concentration, in mg per mL, of USP Fluphenazine Hydrochloride RS in the Standard preparation; V is the volume, in mL, of Elixir taken; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Monograph Ravi Ravichandran, Ph.D.
Principal Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
USP35–NF30 Page 3251
Pharmacopeial Forum: Volume No. 29(6) Page 1888