Cyproheptadine Hydrochloride Oral Solution
» Cyproheptadine Hydrochloride Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of cyproheptadine hydrochloride (C21H21N·HCl).
Packaging and storage Preserve in tight containers.
USP Reference standards 11
USP Cyproheptadine Hydrochloride RS
Identification Place about 50 mL of Oral Solution in a separator, add 25 mL of sodium bicarbonate solution (2 in 100), and extract with three 15-mL portions of isooctane. Wash the combined isooctane extracts with 15 mL of sodium bicarbonate solution (2 in 100), and discard the washing. Evaporate the isooctane solution on a steam bath to dryness, and dissolve the residue in 1 mL of carbon disulfide, filtering if necessary. Determine the IR absorption spectrum as directed under IdentificationOrganic Nitrogenous Bases 181, obtaining the spectrum of USP Cyproheptadine Hydrochloride RS as directed: the Oral Solution meets the requirements of the test.
pH 791: between 3.5 and 4.5.
Methanesulfonic acid solution, Mobile phase, and Chromatographic system Proceed as directed in the Assay under Cyproheptadine Hydrochloride Tablets.
Standard preparation Dissolve an accurately weighed quantity of USP Cyproheptadine Hydrochloride RS in Mobile phase to obtain a solution having a known concentration of about 0.02 mg per mL.
Assay preparation Transfer an accurately measured volume of Oral Solution, equivalent to about 2 mg of cyproheptadine hydrochloride, to a 100-mL volumetric flask. Dilute with Mobile phase to volume, and mix. Pass the solution through a filter having a 0.45-µm or finer porosity.
Procedure Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into 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 C is the concentration, in mg per mL, of USP Cyproheptadine Hydrochloride RS in the Standard preparation; and rU and rS are the cyproheptadine peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2797Pharmacopeial Forum: Volume No. 28(2) Page 272