(dye' bue kane hye'' droe klor' ide).
4-Quinolinecarboxamide, 2-butoxy-N-[2-(diethylamino)ethyl]-, monohydrochloride.
2-Butoxy-N-[2-(diethylamino)ethyl]cinchoninamide monohydrochloride [61-12-1].
» Dibucaine Hydrochloride contains not less than 97.0 percent and not more than 100.5 percent of C20H29N3O2·HCl, calculated on the dried basis.
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
C: A solution of it responds to the tests for Chloride 191 when tested as specified for alkaloidal hydrochlorides.
Loss on drying 731 Dry it at 80 for 5 hours: it loses not more than 2.0% of its weight.
Residue on ignition 281: not more than 0.1%.
Chromatographic purity Dissolve a suitable quantity of Dibucaine Hydrochloride, accurately weighed, in chloroform to obtain a Test solution having a concentration of 40.0 mg per mL. Dissolve a suitable quantity of USP Dibucaine Hydrochloride RS, accurately weighed, in chloroform to obtain a Standard solution having a known concentration of about 40 mg per mL. Dilute portions of this solution quantitatively and stepwise with chloroform to obtain three Comparison solutions having concentrations of 40, 120, and 200 µg per mL (0.1%, 0.3%, and 0.5%) of the Standard solution, respectively. Apply separate 5-µL portions of the five solutions to the starting line of a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Develop the chromatogram in a solvent system consisting of a mixture of toluene, acetone, methanol, and ammonium hydroxide (50:30:5:1) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, mark the solvent front, and air-dry. Spray the plate heavily with a 1 in 200 solution of potassium dichromate in dilute sulfuric acid (1 in 5). Place the plate in an oven at 140 for 10 minutes, and view under short-wavelength UV light: the principal spot obtained from the Test solution corresponds in RF value, color, and intensity to that obtained from the Standard solution; the sum of the intensities of any secondary spots, if present in the chromatogram of the Test solution, corresponds to not more than 1.0%, and the intensity of any secondary spot does not exceed 0.5% of that of the principal spot in the chromatogram of the Standard solution on the basis of comparison with the spots obtained from the Comparison solutions.
Mobile phase, Solvent mixture, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Dibucaine.
Assay preparation Transfer about 100 mg of Dibucaine Hydrochloride, accurately weighed, to a 100-mL volumetric flask, add Solvent mixture to volume, and mix. Pass through a suitable filter having a 0.5-µm or finer porosity.
Procedure Proceed as directed for Procedure in the Assay under Dibucaine. Calculate the quantity, in mg, of C20H29N3O2·HCl in the portion of Dibucaine Hydrochloride taken by the formula:
100C(rU / rS)in which C is the concentration, in mg per mL, of USP Dibucaine Hydrochloride RS in the Standard preparation; and rU and rS are the responses of the dibucaine peaks obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2875Pharmacopeial Forum: Volume No. 31(2) Page 400