Perphenazine Syrup
»Perphenazine Syrup contains not less than 90.0percent and not more than 110.0percent of the labeled amount of perphenazine (C21H26ClN3OS).
Packaging and storage— Preserve in well-closed,light-resistant containers.
USP Reference standards á11ñ USP Perphenazine 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— Add 10mLof water to a volume of Syrup,equivalent to about 4mg of perphenazine,render alkaline by dropwise addition of sodium hydroxide to a pHof 11to 12,and extract with four 5-mLportions of chloroform,combining the extracts through a bed of anhydrous sodium sulfate in a funnel into a beaker.Evaporate the extracts on a steam bath nearly to dryness,and dissolve the residue in 4mLof methanol:the solution so obtained responds to the Identificationtest under Perphenazine Injection.
Uniformity of dosage units á905ñ
FOR SYRUP PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ
FOR SYRUP PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.
Assay—
Acid-alcohol solutionand Palladium chloride solution— Prepare as directed in the Assayunder Perphenazine Injection.
Standard preparation— Dissolve an accurately weighed quantity of USP Perphenazine RSin Acid-alcohol solutionto obtain a solution having a known concentration of about 160µg per mL.
Assay preparation— Transfer an accurately measured volume of Syrup,equivalent to about 6mg of perphenazine,to a 25-mLvolumetric flask,dilute with water to volume,and mix.Transfer 10mLto a 125-mLseparator,add 25mLof water,adjust with ammonium hydroxide to a pHof 10to 11,and extract with four 20-mLportions of chloroform,filtering the extracts through anhydrous sodium sulfate.Evaporate the combined extracts on a steam bath with the aid of a stream of nitrogen to about 5mL.Complete the evaporation without application of heat,and dissolve the residue in 15.0mLof Acid-alcohol solution,filtering if necessary.
Procedure— Mix 10.0mLeach of the Assay preparationand the Standard preparationwith 15.0mLof Palladium chloride solution,filter if necessary,and concomitantly determine the absorbances of these solutions,against a reagent blank,in 1-cm cells at the wavelength of maximum absorbance at about 480nm,with a suitable spectrophotometer.Calculate the quantity,in mg,of perphenazine (C21H26ClN3OS)in each mLof the Syrup taken by the formula:
0.0375(C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Perphenazine RSin the Standard preparation;Vis the volume,in mL,of Syrup taken;and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1521
Pharmacopeial Forum:Volume No.29(6)Page 1963
Phone Number:1-301-816-8165