Assay
Mobile phase
Prepare a suitable filtered and degassed solution containing methanol,water,and glacial acetic acid (85:15:0.5).
Standard preparation
Dissolve an accurately weighed quantity of
USP Padimate O RSin isopropyl alcohol and dilute quantitatively,and stepwise if necessary,with isopropyl alcohol to obtain a solution having a known concentration of about 100µg per mL.
Assay preparation
Transfer an accurately weighed quantity of Lotion,equivalent to about 100mg of Padimate O,to a 100-mLvolumetric flask,and add about 75mLof isopropyl alcohol.Heat gently with swirling until the specimen is dispersed.Cool to room temperature,dilute with isopropyl alcohol to volume,and mix.Pipet 10.0mLof this solution into a 100-mLvolumetric flask,dilute with isopropyl alcohol to volume,and mix.
Chromatographic system
(see
Chromatography á621ñ)The liquid chromatograph is equipped with a 308-nm detector and a 4.6-mm ×25-cm column that contains 5-µm
base-deactivatedpacking L1.The flow rate is about 1.5mLper minute.Chromatograph the
Standard preparation,and record the peak responses as directed under
Procedure:the tailing factor is not more than 2.5and the relative standard deviation for replicate injections is not more than 2.0%.
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 C
17H
27NO
2in the portion of Lotion taken by the formula:
C(rU/rS),
in which
Cis the concentration,in µg per mL,of
USP Padimate O RSin the
Standard preparation,and
rUand
rSare the peak responses for padimate Oobtained from the
Assay preparationand the
Standard preparation,respectively.