Phenelzine Sulfate Tablets
»Phenelzine Sulfate Tablets contain an amount of phenelzine sulfate (C8H12N2·H2SO4)equivalent to not less than 90.0percent and not more than 110.0percent of the labeled amount of phenelzine (C8H12N2).
Packaging and storage— Preserve in tight containers,protected from heat and light.
Identification— Extract a portion of powdered Tablets,equivalent to about 30mg of phenelzine,with 10mLof water,and filter:the filtrate responds to Identificationtests Band Cunder Phenelzine Sulfate.
Disintegration á701ñ— Place 1tablet in each of the 6tubes of the basket and,if the tablets have a soluble external coating,immerse the basket in water at room temperature for 5minutes.Then add a disk to each tube,and operate the apparatus,using simulated gastric fluid TSmaintained at 37±2as the immersion fluid.After 30minutes of operation in simulated gastric fluid TS,lift the basket from the fluid,and observe the tablets.If the tablets have not disintegrated completely,substitute simulated intestinal fluid TSmaintained at 37±2as the immersion fluid.Continue the test for a total period of time,including previous exposure to water and simulated gastric fluid TS,of 1hour and 30minutes.Lift the basket from the fluid,and observe the tablets:all of the tablets have disintegrated completely.If 1or 2tablets fail to disintegrate completely,repeat the test on 12additional tablets:not less than 16of the total 18tablets tested disintegrate completely.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Ion-pair solution— Dissolve about 6.8g of monobasic potassium phosphate and about 2.16g of sodium 1-octanesulfonate in 1000mLof water,and mix.Adjust with phosphoric acid to a pHof 3.0,and filter.
Mobile phase— Prepare a filtered and degassed mixture of Ion-pair solutionand methanol (60:40).Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard preparation— Dissolve an accurately weighed quantity of USP Phenelzine Sulfate RSin Mobile phase,and dilute quantitatively,and stepwise if necessary,with Mobile phaseto obtain a solution having a known concentration of about 258µg per mL.
Assay preparation— Transfer not less than 20Tablets to a suitable container,add about 300mLof Mobile phase,and homogenize until dissolved.Transfer this solution to a 500-mLvolumetric flask,dilute with Mobile phaseto volume,mix,centrifuge,and filter,discarding the first 5mLof the filtrate.Transfer a portion of the filtrate,equivalent to about 12.9mg of phenelzine sulfate,to a 50-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a 210-nm detector and a 3.9-mm ×15-cm column that contains packing L1.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 3000theoretical 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 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in µg,of phenelzine (C8H12N2)in the Assay preparationby the formula:
(136.20/234.27)(50C)(rU/rS),
in which 136.20and 234.27are the molecular weights of phenelzine and phenelzine sulfate,respectively,Cis the concentration,in µg per mL,of USP Phenelzine Sulfate RSin the Standard preparation,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 1528
Phone Number:1-301-816-8330