Cyproheptadine Hydrochloride Oral Solution
(Monograph under this new title—to become official June 1,2005)
(Current monograph title is Cyproheptadine Hydrochloride Syrup)
»Cyproheptadine Hydrochloride Oral Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amount of cyproheptadine hydrochloride (C21H21N·HCl).
Packaging and storage— Preserve in tight containers.
USP Reference standardsá11ñ— USP Cyproheptadine Hydrochloride RS.
Identification— Place about 50mLof Oral Solution in a separator,add 25mLof sodium bicarbonate solution (2in 100),and extract with three 15-mLportions of isooctane.Wash the combined isooctane extracts with 15mLof sodium bicarbonate solution (2in 100),and discard the washing.Evaporate the isooctane solution on a steam bath to dryness,and dissolve the residue in 1mLof carbon disulfide,filtering if necessary.Determine the IRabsorption spectrum as directed under Identification—Organic Nitrogenous Bases á181ñ,obtaining the spectrum of USP Cyproheptadine Hydrochloride RSas directed:the Oral Solution meets the requirements of the test.
pHá791ñ: between 3.5and 4.5.
Assay—
Methanesulfonic acid solution,Mobile phase,andChromatographic system— Proceed as directed in the Assayunder Cyproheptadine Hydrochloride Tablets.
Standard preparation— Dissolve an accurately weighed quantity of USP Cyproheptadine Hydrochloride RSin Mobile phaseto obtain a solution having a known concentration of about 0.02mg per mL.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 2mg of cyproheptadine hydrochloride,to a 100-mLvolumetric flask.Dilute with Mobile phaseto volume,and mix.Pass the solution through a filter having a 0.45-µm or finer porosity.
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 cyproheptadine hydrochloride (C21H21N·HCl)in the portion of Oral Solution taken by the formula:
100C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Cyproheptadine Hydrochloride RSin the Standard preparation;and rUand rSare the cyproheptadine peak responses obtained from the Assay preparationand the Standard preparation,respectively.
(Official June 1,2005)
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 565
Pharmacopeial Forum:Volume No.28(2)Page 272
Phone Number:1-301-816-8379