Identification
A:
Place a volume of Injection,equivalent to about 100mg of triflupromazine hydrochloride,in a test tube,add 5mLof 8Nnitric acid,and mix:a peach to amber color develops,quickly turns dark brown,and then changes to a clear solution having a yellow tint.
C:
The UVabsorption spectrum of the
Assay preparation,prepared as directed in the
Assay,exhibits maxima and minima at the same wavelengths as that of the
Standard preparation,prepared as directed in the
Assay.
Assay
Standard preparation
Transfer about 50mg of
USP Triflupromazine Hydrochloride RS,accurately weighed,to a 50-mLvolumetric flask,dissolve in 0.5Nsulfuric acid,dilute with 0.5Nsulfuric acid to volume,and mix.Proceed as directed under
Assay preparation,beginning with Transfer 10.0mLof this solution to a 100-mLvolumetric flask.The concentration of
USP Triflupromazine Hydrochloride RSin the
Standard preparationis about 5µg per mL.
Assay preparation
Transfer an accurately measured volume of Injection,equivalent to about 50mg of triflupromazine hydrochloride,to a 50-mLvolumetric flask,dilute with 0.5Nsulfuric acid to volume,and mix.Transfer 10.0mLof this solution to a 100-mLvolumetric flask,dilute with the same acid to volume,and mix.Transfer 10.0mLof this solution to a glass-stoppered,50-mLcentrifuge tube containing 10mLof ether previously chilled in an ice bath,insert the stopper,shake for 3minutes,and centrifuge at 1500rpm for 5minutes.Transfer 5.0mLof the aqueous layer to a 100-mLvolumetric flask,dilute with 0.5Nsulfuric acid to volume,and mix.
Procedure
Concomitantly determine the absorbances of the
Assay preparationand the
Standard preparationin 1-cm cells at the wavelength of maximum absorbance at about 255nm,with a suitable spectrophotometer,using 0.5Nsulfuric acid as the blank.Calculate the quantity,in mg,of C
18H
19F
3N
2S·HCl in each mLof the Injection taken by the formula:
(10C/V)(AU/AS),
in which
Cis the concentration,in µg per mL,of
USP Triflupromazine Hydrochloride RSin the
Standard preparation,
Vis the volume,in mL,of Injection taken,and
AUand
ASare the absorbances of the
Assay preparationand the
Standard preparation,respectively.