Amodiaquine Hydrochloride Tablets
» Amodiaquine Hydrochloride Tablets contain an amount of amodiaquine hydrochloride (C20H22ClN3O·2HCl·2H2O) equivalent to not less than 93.0 percent and not more than 107.0 percent of the labeled amount of amodiaquine (C20H22ClN3O).
Packaging and storage Preserve in tight containers.
USP Reference standards 11
A: Infrared Absorption 197K
Test specimen: Powder 1 or more Tablets, and transfer a portion of the powder, equivalent to about 50 mg of amodiaquine, to a 125-mL separator. Add 20 mL of water, and shake for 1 minute. Add 25 mL of chloroform and 1 mL of ammonium hydroxide, shake for 2 minutes, and when settled, filter the chloroform extract through cotton that previously has been rinsed with chloroform, collecting the extract in a vessel suitable for evaporation. Evaporate the chloroform, and dry the residue at 105 for 1 hour.
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.
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 30 minutes.
Procedure Determine the amount of C20H22ClN3O·2HCl·2H2O dissolved from UV absorbances at the wavelength of maximum absorbance at about 342 nm on filtered portions of the solution under test, suitably diluted with water, if necessary, in comparison with a Standard solution having a known concentration of USP Amodiaquine Hydrochloride RS in the same medium.
Tolerances An amount of amodiaquine hydrochloride (C20H22ClN3O·2HCl·2H2O) equivalent to not less than 75% (Q) of the labeled amount of amodiaquine (C20H22ClN3O) is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Buffer solution Weigh about 13.6 g of monobasic potassium phosphate and dissolve in 2 L of water. Add 2.0 mL of perchloric acid, mix, and adjust with phosphoric acid to a pH of 2.5. Pass the solution through a 0.45-µm membrane filter.
Diluent Dilute 10 mL of hydrochloric acid with water to 1 L, and mix.
Mobile phase Prepare a mixture of Buffer solution and methanol (78:22). Make adjustments if necessary (see Chromatography 621).
Standard preparation Transfer an accurately weighed quantity of USP Amodiaquine Hydrochloride RS to a suitable volumetric flask, and dissolve in and dilute with water to volume to obtain a solution having a known concentration of about 0.15 mg per mL of amodiaquine hydrochloride.
Assay preparation Weigh and finely powder 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 7.5 mg of amodiaquine hydrochloride, to a 50-mL volumetric flask, and dissolve in and dilute with Diluent to volume. Sonicate for 25 minutes at 29. Pass a portion of about 10 mL through a 0.2-µm nylon filter, discarding the first 4 mL, and use 2 mL for the analysis.
System suitability solution Transfer an accurately weighed quantity of USP Amodiaquine Hydrochloride RS and USP Chloroquine Phosphate RS to a suitable volumetric flask, and dissolve in and dilute with water to volume to obtain a solution having concentrations of about 0.15 mg per mL of amodiaquine hydrochloride and 0.15 mg per mL of chloroquine phosphate.
Chromatography system (see Chromatography 621) The liquid chromatograph is equipped with a 224-nm detector and 4.6-mm × 10-cm column that contains 5-µm packing L1. The flow rate is about 1.2 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure: the relative retention times are 1.0 for amodiaquine and 0.8 for the chloroquine peaks; the resolution, R, between amodiaquine hydrochloride and chloroquine phosphate is not less than 1.5; for both compounds, the tailing factors are not more than 1.5; and the relative standard deviation is not more than 2.0%.
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 percent of the label claim, of amodiaquine (C20H22ClN3O) in the portion of Tablets taken by the formula:
100(CS / CU)(rU / rS)in which 100 is the percent conversion factor; CS is the concentration, in mg per mL, of USP Amodiaquine Hydrochloride RS in the Standard preparation; CU is the concentration, in mg per mL, of amodiaquine hydrochloride in the Assay preparation, based on the label claim; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2194Pharmacopeial Forum: Volume No. 34(3) Page 558