Identification
A:
The retention time exhibited by theophylline in the chromatogram of the
Assay preparationcorresponds to that of theophylline in the chromatogram of the
Standard preparation,as obtained in the
Assay.
B:
Place a volume of Oral Solution,equivalent to about 100mg of oxtriphylline,in a 60-mLseparator containing 1mLof glacial acetic acid and 40mLof chloroform.Shake for 1minute,allow the phases to separate,and filter the lower phase through dry cotton into a 100-mLbeaker.Transfer a portion of the chloroform solution,equivalent to about 10mg of oxtriphylline,to a porcelain dish,and evaporate on a steam bath with the aid of a current of dry air to dryness.Add 1mLof hydrochloric acid and 100mg of potassium chlorate,evaporate on a steam bath to dryness,and invert the dish over a vessel containing a few drops of 6Nammonium hydroxide:the residue acquires a purple color.
Assay
Assay preparation
Transfer an accurately measured volume of Oral Solution,equivalent to about 100mg of oxtriphylline,to a 1000-mLvolumetric flask,dilute with water to volume,and mix.
Procedure
Proceed as directed for
Procedurein the
Assayunder
Oxtriphylline Delayed-release Tablets.Calculate the quantity,in mg,of C
7H
8N
4O
2in each mLof the Oral Solution taken by the formula:
(180.17/283.33)(C/V)(rU/rS),
in which
Vis the volume,in mL,of Oral Solution taken to prepare the
Assay preparation,and the other terms are as defined therein.