Procedure
Separately inject equal volumes (about 10µL)of the
Standard preparationand the
Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of cephradine (sum of cephradine and cephalexin)in each Tablet taken by the formula:
(CP)(L/1000D)(rU/rS),
in which
Cis the concentration,in mg per mL,of
USP Cephradine RSin the
Standard preparation,
Pis the designated potency,in µg per mg,of
USP Cephradine RS,
Lis the labeled quantity,in mg of cephradine,in each Tablet,
Dis the concentration,in mg of cephradine per mL,of the
Assay preparation,based on the labeled quantity per Tablet,the number of Tablets taken,and the extent of dilution,and
rUand
rSare the sums of the cephradine and cephalexin peak responses obtained from the
Assay preparationand the
Standard preparation,respectively.