Meclocycline Sulfosalicylate Cream
»Meclocycline Sulfosalicylate Cream contains the equivalent of not less than 90.0percent and not more than 125.0percent of the labeled amount of meclocycline (C22H21ClN2O8).
Packaging and storage— Preserve in tight containers,protected from light.
Minimum fill á755ñ: meets the requirements.
Assay—
Mobile phase— Prepare as directed in the Assayunder Meclocycline Sulfosalicylate.
Standard preparation— Transfer 36mg of USP Meclocycline Sulfosalicylate RS,accurately weighed,to a 50-mLvolumetric flask,dilute with methanol to volume,and mix.Transfer 2.0mLof this solution to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix to obtain a solution having a known concentration of about 10µg of meclocycline per mL.
Assay preparation— Transfer an accurately weighed quantity of Cream,equivalent to about 5mg of meclocycline,to a glass-stoppered,50-mLcentrifuge tube,add 20mLof methanol and 20mLof 0.025Nsulfuric acid,and shake vigorously for 15minutes.Transfer the solution to a 50-mLvolumetric flask,rinsing the centrifuge tube with two 5-mLportions of methanol and adding the rinsings to the flask,dilute with methanol to volume,and mix.Centrifuge a portion of this solution for 5minutes,transfer 5mLof the supernatant to a 50-mLvolumetric flask,dilute with Mobile phaseto volume,mix,and filter.
Procedure— Proceed as directed in the Assayunder Meclocycline Sulfosalicylate.Calculate the quantity,in mg,of meclocycline (C22H21ClN2O8)in the portion of Cream taken by the formula:
0.5C(rU/rS),
in which Cis the concentration,in µg per mL,of meclocycline in the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1195
Phone Number:1-301-816-8335