Mefloquine Hydrochloride Tablets
DEFINITION
Mefloquine Hydrochloride Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of mefloquine hydrochloride (C17H16F6N2O·HCl).
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.
• B. Ultraviolet Absorption 
197U
197U
Diluent, Standard solution, and Sample solution:
Proceed as directed in the Assay.
Blank:
Diluent
ASSAY
• Procedure
Buffer:
2.72 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:
0.05 mg/mL of Mefloquine Hydrochloride in Diluent from the Sample stock solution
Chromatographic system
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 C17H16F6N2O·HCl in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Mefloquine Hydrochloride RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of Mefloquine Hydrochloride in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–110.0%
PERFORMANCE TESTS
• Dissolution 711
711
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. [Note—Use 5% of the flask volume of methanol to facilitate dissolution before solubilization with Medium. ]
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.
Spectrometric conditions
Mode:
UV absorption spectroscopy
Analytical wavelength:
UV 285 nm
Cell length:
1 cm
Blank:
Medium
Analysis
Calculate the percentage of C17H16F6N2O·HCl dissolved:
Result = (AU/AS) × (CS/L) × D × V × 100
| AU | = | = absorbance of mefloquine from the Sample solution |
| AS | = | = absorbance of mefloquine from the Standard solution |
| CS | = | = concentration of USP Mefloquine Hydrochloride RS in the Standard solution (mg/mL) |
| D | = | = dilution factor of the Sample solution |
| L | = | = label claim (mg/Tablet) |
| V | = | = volume of Medium, 900 mL |
Tolerances:
NLT 80% (Q) of the labeled amount of C17H16F6N2O·HCl is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
IMPURITIES
Organic Impurities
• Procedure
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 = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of each impurity from the Sample solution |
| rS | = | = peak response of mefloquine hydrochloride from the Standard solution |
| CS | = | = concentration of USP Mefloquine Hydrochloride RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of Mefloquine Hydrochloride in the Sample solution (mg/mL) |
Acceptance criteria
Individual impurities:
See Impurity 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%. ]
Total impurities:
NMT 0.50%
Impurity Table 1
| Name | Relative Retention Time |
Acceptance Criteria, NMT (%) |
|
|---|---|---|---|
| Specified (unidentified) | 0.67 | 0.15 | |
| Specified (unidentified) | 0.70 | 0.15 | |
threo-Mefloquine (dl-threo- -2-piperidyl-2,8-bis(trifluoromethyl)-4-quinolinemethanol) |
0.75 | — | |
| Specified (unidentified) | 0.84 | 0.25 | |
| Mefloquine hydrochloride | 1.0 | — | |
| Any other unknown individual impurity | — | 0.15 | |
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers. Store at controlled room temperature.
• USP Reference Standards 11
11
USP Mefloquine Hydrochloride RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Leonel M. Santos, Ph.D.
Senior Scientific Liaison 1-301-816-8168 |
(SM12010) Monographs - Small Molecules 1 |
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3784
Pharmacopeial Forum: Volume No. 36(3) Page 674