Sumatriptan Compounded Oral Suspension
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Sumatriptan Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of sumatriptan (C14H21N3O2S).
Prepare Sumatriptan Compounded Oral Suspension containing 5 mg/mL of sumatriptan as follows (see Pharmaceutical Compounding— Nonsterile Preparations 〈795〉).
| Sumatriptan (as Sumatriptan Succinate) | 500 mg (700 mg) |
| Vehicle: a 1:1 mixture of Vehicle for Oral Solution (regular or sugar- free), NF, and Vehicle for Oral Suspension, NF, a sufficient quantity to make | 100 mL |
Place the required number of tablets in a suitable mortar, and comminute to a fine powder, or add Sumatriptan Succinate powder to the mortar. Add 25 mL of Vehicle in portions, mixing thoroughly after each addition. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add sufficient Vehicle to bring to final volume, and mix well.
2 ASSAY
PROCEDURE
Mobile phase: Acetonitrile and 0.01 M dibutylamine in 0.025 M aqueous monobasic sodium phosphate dihydrate (25:75), adjusted with 1 N sodium hydroxide to a pH of 8.0. Filter and degas.
Standard stock solution: 4.0 mg/mL of USP Sumatriptan Succinate RS in Mobile phase
Standard solution: 0.12 mg/mL of sumatriptan prepared with Standard stock solution and Mobile phase
Sample solution: 0.15 mg/mL of sumatriptan prepared from Oral Suspension and 0.1 M hydrochloric acid. Pass through a 0.22-µm syringe filter into a 0.3-mL polypropylene sample vial.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 282 nm
Column: 4.6-mm × 10-cm; 5-µm packing L1
Flow rate: 1.5 mL/min
Injection volume: 10 µL
System suitability
Sample: Standard solution
[NOTE—The retention time for sumatriptan is about 11 min.]
Suitability requirements
Relative standard deviation: NMT 1.5% for replicate injections
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of sumatriptan (C14H21N3O2S) in the portion of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
rU = peak response from the Sample solution
rS = peak response from the Standard solution
CS = concentration of sumatriptan in the Standard solution (mg/mL)
CU = nominal concentration of sumatriptan in the Sample solution (mg/mL)
Acceptance criteria: 90.0%–110.0%
3 SPECIFIC TESTS
PH 〈791〉: 3.6–4.6
4 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Package in tight, light-resistant containers. Store in a refrigerator.
BEYOND-USE DATE: NMT 14 days after the date on which it was compounded when stored in a refrigerator
LABELING: Label it to state that it is to be well shaken before use, and to state the Beyond-Use Date.
USP REFERENCE STANDARDS 〈11〉
USP Sumatriptan Succinate RS
