Sumatriptan Tablets
DEFINITION
Sumatriptan Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of sumatriptan (C14H21N3O2S).
IDENTIFICATION
• A. Infrared Absorption 
197K
:
The IR spectrum exhibits main bands at or near (±1) wave numbers (cm
1) 1708, 1567, 1339, 1300, 1235, 1207, 989, and 844.
197K:
The IR spectrum exhibits main bands at or near (±1) wave numbers (cm1) 1708, 1567, 1339, 1300, 1235, 1207, 989, and 844.
• B.
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Buffer solution A:
2.93 g/L of monobasic sodium phosphate, 1.3 mL/L of dibutylamine, and 0.4 mL/L of phosphoric acid in water. Adjust with 10 N sodium hydroxide to a pH of 6.5.
Buffer solution B:
3.9 g/L of monobasic sodium phosphate. Adjust with 10 N sodium hydroxide to a pH of 6.5 before dilution.
Mobile phase:
Acetonitrile and Buffer solution A (1:3)
Diluent:
Acetonitrile and Buffer solution B (1:3)
Standard solution:
Equivalent to 0.1 mg/mL of sumatriptan from USP Sumatriptan Succinate RS in Diluent
Sample solution:
Nominally 0.1 mg/mL of sumatriptan in Diluent. [Note—Sonicate if necessary. ]
Chromatographic system
Mode:
LC
Detector:
UV 282 nm
Column:
4.6-mm × 25-cm; 5-µm packing L1
Flow rate:
1.5 mL/min
Injection size:
10 µL
Run time:
10 min
System suitability
Sample:
Standard solution
Suitability requirements
Tailing factor:
NMT 2.0
Relative standard deviation:
NMT 1.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of sumatriptan (C14H21N3O2S) in the portion of Tablets taken:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Sumatriptan Succinate RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of the Sample solution (mg/mL) |
| Mr1 | = | = molecular weight of sumatriptan, 295.4 |
| Mr2 | = | = molecular weight of sumatriptan succinate, 413.5 |
Acceptance criteria:
90.0%–110.0% of the labeled amount of sumatriptan (C14H21N3O2S).
PERFORMANCE TESTS
• Dissolution 711
711
Test 1
Medium:
0.01 N hydrochloric acid; 900 mL
Apparatus 2:
30 rpm
Time:
15 min
Standard solution:
0.025 mg/mL of USP Sumatriptan Succinate RS in Medium
Sample solution:
Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size. Dilute with Medium if necessary.
Instrumental conditions
Mode:
Spectrophotometry
Detector:
UV 282 nm
Blank:
Medium
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of sumatriptan (C14H21N3O2S) dissolved:
Result = (AU/AS) × (CS/L) × D × V × (Mr1/Mr2) × 100
| AU | = | = absorbance of the Sample solution |
| AS | = | = absorbance of the Standard solution |
| CS | = | = concentration of the Standard solution (mg/mL) |
| L | = | = label claim (mg/Tablet) |
| D | = | = dilution factor of the Sample solution |
| V | = | = volume of Medium, 900 mL |
| Mr1 | = | = molecular weight of sumatriptan, 295.4 |
| Mr2 | = | = molecular weight of sumatriptan succinate, 413.5 |
Tolerances:
NLT 80% (Q) of the labeled amount of sumatriptan 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:
15 min
Standard solution:
(L/900) mg/mL of USP Sumatriptan Succinate RS in Medium, where L is the Tablet label claim in mg
Sample solution:
Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size.
Instrumental conditions
Mode:
Spectrophotometry
Detector:
UV 282 nm
Cell path length:
1 cm
Blank:
Medium
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of sumatriptan (C14H21N3O2S) dissolved:
Result = (AU/AS) × (CS/L) × V × (Mr1/Mr2) × 100
| AU | = | = absorbance of the Sample solution |
| AS | = | = absorbance of the Standard solution |
| CS | = | = concentration of the Standard solution (mg/mL) |
| L | = | = label claim (mg/Tablet) |
| V | = | = volume of Medium, 900 mL |
| Mr1 | = | = molecular weight of sumatriptan, 295.4 |
| Mr2 | = | = molecular weight of sumatriptan succinate, 413.5 |
Tolerances:
NLT 80% (Q) of the labeled amount of sumatriptan is dissolved.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers. Store between 2
and 30.
and 30.
• 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
11
USP Sumatriptan Succinate RS 
1H-Indole-5-methanesulfonamide, 3-[2-(dimethylamino)ethyl]-N-methyl-, butanedioate (1:1).
C14H21N3O2S·C4H6O4 413.49
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1H-Indole-5-methanesulfonamide, 3-[2-(dimethylamino)ethyl]-N-methyl-, butanedioate (1:1).
C14H21N3O2S·C4H6O4 413.49
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Hariram Ramanathan, M.S.
Associate Scientific Liaison 1-301-816-8313 |
(SM42010) Monographs - Small Molecules 4 |
| 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 4732
Pharmacopeial Forum: Volume No. 35(4) Page 871