Assay
Mobile phase
Prepare a filtered and degassed solution of 0.17Nacetic acid.Make adjustments if necessary (see
System Suitabilityunder
Chromatography á621ñ).
Standard preparation
Dissolve an accurately weighed quantity of
USP Epinephrine Bitartrate RSin
Mobile phaseto obtain a solution having a known concentration of about 150µg per mL.
Assay preparation
Transfer about 25mg of Racepinephrine Hydrochloride,accurately weighed,to a 100-mLvolumetric flask.Dissolve in and dilute with Mobile phaseto volume,and mix.Transfer 4.0mLof this solution to a 10-mLvolumetric flask,dilute with Mobile phaseto volume,and mix to obtain a solution containing about 100µg per mL.
Chromatographic system
(see
Chromatography á621ñ)The liquid chromatograph is equipped with a 278-nm detector and a 4.6-mm ×15-cm column that contains packing L1.The flow rate is about 2.0mLper minute.Chromatograph the
Standard preparation,and record the peak responses as directed for
Procedure:the relative standard deviation for replicate injections is not more than 2.0%.
Procedure
Separately inject equal volumes (about 25µL)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 C
9H
13NO
3·HCl in the portion of Racepinephrine Hydrochloride taken by the formula:
0.25C(219.67/333.30)(RU/RS),
in which
Cis the concentration,in µg per mL,of
USP Epinephrine Bitartrate RSin the
Standard preparation,219.67and 333.30are the molecular weights of racepinephrine hydrochloride and epinephrine bitartrate,respectively,and
RUand
RSare the peak responses obtained from the
Assay preparationand the
Standard preparation,respectively.