Mefloquine 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)

DOWNLOAD PDF HERE

1 DEFINITION

Mefloquine Hydrochloride Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of mefloquine hydrochloride (C₁₇H₁₆F₆N₂O · HCl).

2 IDENTIFICATION

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Change to read:

B. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U (CN 1-May-2020)

Diluent, Standard solution, and Sample solution: Proceed as directed in the Assay.

Blank: Diluent

3 ASSAY

Procedure

Buffer: 2.7 g/L of monobasic potassium phosphate. Adjust with phosphoric acid to a pH of 3.0 ± 0.1.

Diluent: Methanol and water (23:27)

Mobile phase: Methanol, acetonitrile, and Buffer (13:10:27)

Standard solution: 0.05 mg/mL of USP Mefloquine Hydrochloride RS in Diluent

Sensitivity solution: 0.025 μg/mL of USP Mefloquine Hydrochloride RS in Diluent

Sample stock solution: Transfer a suitable number of Tablets to a volumetric flask, dilute with methanol (approximately 80% of the total volume), shake for 30 min, allow to sit for 1 h, and dilute with methanol to volume to obtain a solution having a concentration of 2.5 mg/mL of mefloquine hydrochloride.

Sample solution: Nominally 0.05 mg/mL of mefloquine hydrochloride in Diluent from the Sample stock solution

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 222 nm

Column: 4.6-mm × 15-cm; 5-μm packing L68

Flow rate: 1 mL/min

Injection size: 10 μL

System suitability

Samples: Standard solution and Sensitivity solution

Suitability requirements

Column efficiency: NLT 4000 theoretical plates, Standard solution

Tailing factor: NMT 1.5, Standard solution

Signal-to-noise ratio: NLT 5, Sensitivity solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of mefloquine hydrochloride (C₁₇H₁₆F₆N₂O · HCl) 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 USP Mefloquine Hydrochloride RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Test 1

Medium: 0.1 N hydrochloric acid; 900 mL

Apparatus 2: 50 rpm

Time: 30 min

Standard stock solution: 0.2 mg/mL of USP Mefloquine Hydrochloride RS in Medium. A small amount of methanol, not exceeding 5% of the final volume, may be used to help solubilize mefloquine.

Standard solution: 0.04 mg/mL of USP Mefloquine Hydrochloride RS in Medium from the Standard stock solution

Sample solution: Dilute a portion of the solution under test with Medium (1:5), and pass a portion through a suitable filter of 0.8-μm pore size.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: UV

Analytical wavelength: 285 nm

Cell length: 1 cm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of mefloquine hydrochloride (C₁₇H₁₆F₆N₂O · HCl) dissolved:

Result = (A_U /A_S ) × (C_S /L) × D × V × 100

A_U= absorbance from the Sample solution

A_S = absorbance from the Standard solution

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

L = label claim (mg/Tablet)

D = dilution factor of the Sample solution

V = volume of Medium, 900 mL

Tolerances: NLT 80% (Q) of the labeled amount of mefloquine hydrochloride (C₁₇H₁₆F₆N₂O · HCl) is dissolved.

Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.

Medium: 0.01 N hydrochloric acid; 900 mL

Apparatus 2: 50 rpm

Time: 30 min

Standard solution: 0.278 mg/mL of USP Mefloquine Hydrochloride RS in Medium. A small amount of methanol, not exceeding 2.5% of the final volume, may be used to help solubilize mefloquine.

Sample solution: Pass a portion of the solution under test through a suitable filter.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: UV

Analytical wavelength: 284 nm

Cell length: 0.2 cm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of mefloquine hydrochloride (C₁₇H₁₆F₆N₂O · HCl) dissolved:

Result = (A_U /A_S) × (C_S /L) × V × 100

A_U = absorbance from the Sample solution

A_S = absorbance from the Standard solution

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

L = label claim (mg/Tablet)

V = volume of Medium, 900 mL

Tolerances: NLT 75% (Q) of the labeled amount of mefloquine hydrochloride (C₁₇H₁₆F₆N₂O · HCl) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Organic Impurities

Buffer, Diluent, Mobile phase, Standard solution, Sensitivity solution, Sample stock solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each impurity in the portion of Tablets taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of each impurity from the Sample solution

r_S = peak response of mefloquine hydrochloride from the Standard solution

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

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

Acceptance criteria: See Table 1.

[Note—Do not include the threo isomer, a process impurity monitored in the drug substance, in the calculation of total impurities. Disregard any peak less than 0.05%.]

Table 1

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers. Store at controlled room temperature.

Labeling: When more than one Dissolution test is given, the labeling states the Dissolution test used only if Test 1 is not used.

USP Reference Standards 〈11〉

USP Mefloquine Hydrochloride RS