Amodiaquine Hydrochloride Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Amodiaquine Hydrochloride Tablets contain an amount of amodiaquine hydrochloride (C₂₀H₂₂ClN₃O · 2HCl · 2H₂O) equivalent to NLT 93.0% and NMT 107.0% of the labeled amount of amodiaquine (C₂₀H₂₂ClN₃O).

2 IDENTIFICATION

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A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

Sample: Powder 1 or more Tablets, and transfer a portion of the powder, equivalent to 50 mg of amodiaquine, to a 125-mL separator. Add 20 mL of water, and shake for 1 min. Add 25 mL of chloroform and 1 mL of ammonium hydroxide, shake for 2 min, 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 h.

Acceptance criteria: Meet the requirements

B. The retention time of the amodiaquine hydrochloride peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

3.1 Procedure

Buffer: 6.8 g/L of monobasic potassium phosphate in water. Add 1.0 mL of perchloric acid to each 1 L of solution, adjust with phosphoric acid to a pH of 2.5, and pass through a filter of 0.45-μm pore size.

Diluent: 1% (v/v) hydrochloric acid in water

Mobile phase: Methanol and Buffer (22:78)

Standard solution: 0.15 mg/mL of USP Amodiaquine Hydrochloride RS and 0.15 mg/mL of USP Chloroquine Phosphate RS in water

Sample solution: Transfer a quantity equivalent to 7.5 mg of amodiaquine hydrochloride from finely powdered Tablets (NLT 20) to a 50-mL volumetric flask, and dissolve in and dilute with Diluent to volume. Sonicate for 25 min at 29°. Pass 10 mL through a nylon filter of 0.2-μm pore size, discarding the first 4 mL. Use 2 mL for the analysis.

3.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 224 nm

Column: 4.6-mm × 10-cm; 5-μm packing L1

Flow rate: 1.2 mL/min

Injection volume: 10 μL

3.3 System suitability

Sample: Standard solution

[Note - The relative retention times for the chloroquine and amodiaquine peaks are 0.8 and 1.0, respectively.]

3.4 Suitability requirements

Resolution: NLT 1.5 between amodiaquine hydrochloride and chloroquine phosphate

Tailing factor: NMT 1.5 for amodiaquine hydrochloride and chloroquine phosphate

Relative standard deviation: NMT 2.0% for amodiaquine hydrochloride and chloroquine phosphate

3.5 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of amodiaquine (C₂₀H₂₂ClN₃O) in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of amodiaquine in USP Amodiaquine Hydrochloride RS in the Standard solution (mg/mL)

C_U = nominal concentration of amodiaquine in the Sample solution (mg/mL)

Acceptance criteria: 93.0%–107.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: Water; 900 mL

Apparatus 2: 50 rpm

Time: 30 min

Detector: UV 342 nm

Standard solution: USP Amodiaquine Hydrochloride RS in Medium

Sample solution: Filter 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.

Analysis

Samples: Standard solution and Sample solution

Determine the amount of amodiaquine hydrochloride (C₂₀H₂₂ClN₃O · 2HCl · 2H₂O) dissolved from UV absorbances.

Tolerances: An amount of amodiaquine hydrochloride (C₂₀H₂₂ClN₃O · 2HCl · 2H₂O) equivalent to NLT 75% (Q) of the labeled amount of amodiaquine (C₂₀H₂₂ClN₃O) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Amodiaquine Hydrochloride RS

USP Chloroquine Phosphate RS