Amodiaquine Hydrochloride
C20H22ClN3O·2HCl·2H2O
464.81
464.81Phenol, 4-[(7-chloro-4-quinolinyl)amino]-2-[(diethylamino)-methyl]-, dihydrochloride, dihydrate.
4-[(7-Chloro-4-quinolyl)amino]-
-(diethylamino)-o-cresol dihydrochloride dihydrate
[6398-98-7].Anhydrous 428.79
[69-44-3].» Amodiaquine Hydrochloride contains not less than 97.0 percent and not more than 103.0 percent of C20H22ClN3O·2HCl, calculated on the anhydrous basis.
Packaging and storage—
Preserve in tight containers.
Completeness of solution 
641
—
A solution of 200 mg in 10 mL of water is clear.
641—
A solution of 200 mg in 10 mL of water is clear.
Identification—
A:
Infrared Absorption 197K—Prepare the test specimen as follows. Dissolve 20 mg in 10 mL of water in a separator, add 1 mL of ammonium hydroxide, and extract by shaking with 25 mL of chloroform. Draw off and evaporate the chloroform extract, and dry the residue at 105
for 2 hours.
197K—Prepare the test specimen as follows. Dissolve 20 mg in 10 mL of water in a separator, add 1 mL of ammonium hydroxide, and extract by shaking with 25 mL of chloroform. Draw off and evaporate the chloroform extract, and dry the residue at 105 for 2 hours.
B:
Ultraviolet Absorption 197U—
197U—
Solution:
10 µg per mL.
Medium:
dilute hydrochloric acid (1 in 100).
C:
A solution of it responds to the tests for Chloride 191.
191.
Water, Method I 921:
not less than 7.0% and not more than 9.0%.
921:
not less than 7.0% and not more than 9.0%.
Residue on ignition 281:
not more than 0.2%.
281:
not more than 0.2%.
Chromatographic purity—
Standard solutions—
To 20 mg of USP Amodiaquine Hydrochloride RS in a glass-stoppered test tube add 1.0 mL of chloroform (saturated with ammonium hydroxide), and shake vigorously for 2 minutes. Allow the solids to settle, and decant the liquid into a second test tube (Standard solution A). Prepare a second solution by diluting 1.0 volume of Standard solution A with sufficient chloroform (saturated with ammonium hydroxide) to obtain 200 volumes of solution (Standard solution B).
Test solution—
To 200 mg of Amodiaquine Hydrochloride in a glass-stoppered test tube add 10 mL of chloroform (saturated with ammonium hydroxide), and shake vigorously for 2 minutes. Allow the solids to settle, and decant the liquid into a second test tube.
Procedure—
Apply 10 µL portions of Standard solution A, Standard solution B, and the Test solution to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of chloroform (saturated with ammonium hydroxide) and dehydrated alcohol (9:1) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, allow the solvent to evaporate, and examine the plate under short-wavelength UV light: the chromatograms show principal spots at about the same RF value, and no secondary spot, if present in the chromatogram from the Test solution, is more intense than the principal spot obtained from Standard solution B.
621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of chloroform (saturated with ammonium hydroxide) and dehydrated alcohol (9:1) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, allow the solvent to evaporate, and examine the plate under short-wavelength UV light: the chromatograms show principal spots at about the same RF value, and no secondary spot, if present in the chromatogram from the Test solution, is more intense than the principal spot obtained from Standard solution B.
Assay—
Transfer about 300 mg of Amodiaquine Hydrochloride, accurately weighed, to a 200-mL volumetric flask, add dilute hydrochloric acid (1 in 100) to volume, and mix. Pipet 10.0 mL of the solution into a 1000-mL volumetric flask, add dilute hydrochloric acid (1 in 100) to volume, and mix. Concomitantly determine the absorbances of this solution and a solution of USP Amodiaquine Hydrochloride RS in the same medium having a known concentration of about 15 µg per mL, in 1-cm cells at the wavelength of maximum absorbance at about 342 nm, with a suitable spectrophotometer, using dilute hydrochloric acid (1 in 100) as the blank. Calculate the quantity, in mg, of C20H22ClN3O·2HCl in the portion of Amodiaquine Hydrochloride taken by the formula:
20C(AU / AS)
in which C is the concentration, in µg per mL, of USP Amodiaquine Hydrochloride RS in the Standard solution; and AU and AS are the absorbances of the solution of Amodiaquine Hydrochloride and the Standard solution, respectively.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| Topic/Question | Contact | Expert Committee |
| Monograph | Behnam Davani, Ph.D., M.B.A.
Senior Scientist 1-301-816-8394 |
(MDAA05) Monograph Development-Antivirals and Antimicrobials |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 1538
Pharmacopeial Forum: Volume No. 34(2) Page 243
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.