Assay—
Standard preparation—
Dissolve a suitable quantity of
USP Dipivefrin Hydrochloride RS, accurately weighed, in 0.0015 N hydrochloric acid to obtain a solution having a known concentration of about 1 mg per mL.
Assay preparation—
Transfer an accurately measured volume of Ophthalmic Solution, equivalent to about 25 mg of dipivefrin hydrochloride, to a 25-mL volumetric flask, dilute with 0.0015 N hydrochloric acid to volume, if necessary, and mix.
Procedure—
Proceed as directed in the
Assay under
Dipivefrin Hydrochloride. Calculate the quantity, in mg, of C
19H
29NO
5·HCl in each mL of the Ophthalmic Solution taken by the formula:
(25C / V)(rU / rS),
in which
C is the concentration, in mg per mL, of
USP Dipivefrin Hydrochloride RS in the
Standard preparation; V is the volume, in mL, of Ophthalmic Solution taken; and
rU and
rS are the peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.
71
:
meets the requirements.