(naf' ti feen hye'' droe klor' ide).
1-Naphthalenemethanamine, N-methyl-N-(3-phenyl-2-propenyl)-, hydrochloride (E)-.
(E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride [65473-14-5].
» Naftifine Hydrochloride contains not less than 99.0 percent and not more than 101.0 percent of C21H21N·HCl, calculated on the dried basis.
Packaging and storage Preserve in tight containers.
USP Reference standards 11
Identification, Infrared Absorption 197K.
Melting range 741: between 175 and 179.
Loss on drying 731 Dry over phosphorus pentoxide at 105 for 4 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Heavy metals, Method II 231: 0.001%.
Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay.
Test preparation Use the Assay preparation.
Procedure Inject a volume (about 15 µL) of the Test preparation into the chromatograph, record the chromatogram, and measure the peak responses. Calculate the percentage of each impurity in the portion of Naftifine Hydrochloride taken by the formula:
100(ri / rS)in which ri is the peak response for each impurity, and rS is the sum of the responses of all of the peaks: not more than 0.1% of any individual impurity is found, and the sum of all impurities is not more than 1.0%.
Mobile phase Prepare a filtered and degassed mixture of n-hexane, alcohol, dimethylformamide, and formic acid (200:60:40:2), cover tightly with a moisture-proof film, and allow to stand for 12 hours at room temperature. Make adjustments, if necessary (see System Suitability under Chromatography 621).
Standard preparation Dissolve an accurately weighed quantity of USP Naftifine Hydrochloride RS in Mobile phase, and dilute quantitatively, and stepwise, if necessary, with Mobile phase to obtain a solution having a known concentration of about 0.2 mg per mL.
Assay preparation Transfer about 10 mg of Naftifine Hydrochloride, accurately weighed, to a 50-mL volumetric flask, dissolve in and dilute with Mobile phase to volume.
Chromatographic system (see Chromatography 621)The liquid chromatograph is equipped with a 270-nm detector and a 4.6-mm × 25-cm column that contains 5-µm packing L3. The flow rate is about 2.0 mL per minute.
Procedure Separately inject equal volumes (about 15 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 C21H21N·HCl in the portion of Naftifine Hydrochloride taken by the formula:
50C(rU / rS)in which C is the concentration, in mg per mL, of USP Naftifine Hydrochloride RS in the Standard preparation, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 3983