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.

A: Infrared Absorption á197Kñ.

B: Ultraviolet Absorption á197Uñ—

C: Asolution of Fluphenazine Hydrochloride responds to the tests for Chloride á191ñ.

Test solution: 0.1Mmethanolic sodium hydroxide.

Standard solution: 0.1Mmethanolic sodium hydroxide.

Eluant: a mixture of acetone,cyclohexane,and diethylamine (40:15:1).

Visualization: 1.

Diluent solution— Prepare a filtered and degassed mixture of 0.05Mmonobasic potassium phosphate (adjusted with phosphoric acid to a pHof 2.5),acetonitrile,and methanol (40:30:30).Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).

Mobile phase— Prepare a mixture containing 0.2%triethylamine in Diluent solution.

Standard preparation— Dissolve an accurately weighed quantity of USP Fluphenazine Hydrochloride RSin Diluent solution,and dilute quantitatively,and stepwise if necessary,with Diluent solutionto obtain a solution having a known concentration of about 0.06mg per mL.

Assay preparation— Transfer about 120mg of Fluphenazine Hydrochloride,accurately weighed,to a 100-mLvolumetric flask.Dissolve in and dilute with Diluent solutionto volume,and mix.Pipet 5.0mLof this solution into a 100-mLvolumetric flask,dilute with Diluent solutionto volume,and mix.Filter,discarding the first 5mLof the filtrate.

Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a 254-nm detector and a 4-mm ×12.5-cm column that contains packing L7.The flow rate is about 1.0mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure :the column efficiency is not less than 2000theoretical plates,the tailing factor is not more than 2.0,and the relative standard deviation for replicate injections is not more than 2.0%.

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 C22H26F3N3OS·2HCl in the portion of Fluphenazine Hydrochloride taken by the formula: in which Cis the concentration,in mg per mL,of USP Fluphenazine Hydrochloride RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.