Padimate O Lotion
»Padimate O Lotion contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C17H27NO2.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
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 C17H27NO2in 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.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1459
Pharmacopeial Forum:Volume No.30(2)Page 527
Phone Number:1-301-816-8389