PROCEDURE FOR CONTENT UNIFORMITY
Alkaline borate solution
Dissolve 6.2g of boric acid and 7.45g of potassium chloride in 500mLof water,add 210mLof sodium hydroxide solution (1in 25),and mix.Add water to make 2000mLof solution,and mix.
Standard solution
[NOTEPrepare the
Standard solution and the
Test solution concomitantly.
]Dissolve an accurately weighed quantity of
USP Mephobarbital RSin
Alkaline borate solutionto obtain a solution having a concentration of about 10mg per mL,and quantitatively dilute with water to obtain a solution having a known concentration of about 1.5mg per mL.
Test solution
Transfer 1Tablet to a glass-stoppered centrifuge tube,crush the tablet,and add 25.0mLof Alkaline borate solution.Insert the stopper,shake for 10minutes,and centrifuge until clear,filtering the supernatant,if necessary.Dilute a portion of the subsequent liquid quantitatively,and stepwise if necessary,with water to obtain a solution having a concentration of about 1.5mg of mephobarbital per mL.
Procedure
Transfer 3.0mLeach of the
Standard solutionand the
Test solutionto separate 200-mLvolumetric flasks,dilute each with a 1in 3solution of
Alkaline borate solutionin water to volume,and mix.Concomitantly determine the absorbances of the solutions in 1-cm cells at the wavelength of maximum absorbance at about 245nm,with a suitable spectrophotometer,using a 1in 3solution of
Alkaline borate solutionin water as the blank.Calculate the quantity,in mg,of C
13H
14N
2O
3in the Tablet taken by the formula:
(TC/D)(AU/AS),
in which
Tis the labeled quantity,in mg,of mephobarbital in the Tablet;
Cis the concentration,in mg per mL,of
USP Mephobarbital RSin the
Standard solution;Dis the concentration,in mg per mL,of mephobarbital in the
Test solution,based upon the labeled quantity per Tablet and the extent of dilution;and
AUand
ASare the absorbances of the solutions from the
Test solutionand the
Standard solution,respectively.