Cyproheptadine Hydrochloride Syrup, chemical structure, molecular formula, Reference Standards

Cyproheptadine Hydrochloride Syrup

(Current title—not to change until June 1,2005)

Monograph title change—to become official June 1,2005

See Cyproheptadine Hydrochloride Oral Solution

»Cyproheptadine Hydrochloride Syrup contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C21H21N·HCl.

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Cyproheptadine Hydrochloride RS.

Identification— Place about 50mLof Syrup 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 Syrup meets the requirements of the test.

pHá791ñ: between 3.5and 4.5.

Assay—

Methanesulfonic acid solution,Mobile phase,andChromatographic system— Proceed as directed under 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 Syrup,equivalent to about 2mg of cyproheptadine hydrochloride,to a 100-mLvolumetric flask.Dilute with Mobile phaseto volume,and mix.Filter the solution through a filter having a porosity of 0.45µm or finer.

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 C21H21N·HCl in the portion of Syrup 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.

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