Naratriptan Hydrochloride Oral Suspension
DEFINITION
Naratriptan Hydrochloride Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled content of naratriptan hydrochloride (C17H25N3O2S·HCl). Prepare Naratriptan Hydrochloride Oral Suspension (0.55 mg/mL) equivalent to 0.5 mg of Naratriptan per mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 
795
).
795). | Naratriptan (as Hydrochloride) | 50 mg (55 mg) |
| Vehicle: A mixture of Vehicle for Oral Solution, NF (regular or sugar-free), and Vehicle for Oral Suspension, NF (1:1), a sufficient quantity to make | 100 mL |
Calculate the required quantity of each ingredient for the total amount to be prepared. If using tablets, place the required number of tablets in a suitable mortar, and comminute the tablets to a fine powder or add Naratriptan Hydrochloride powder. Add the Vehicle in small portions and triturate to make a smooth paste. Add increasing volumes of the Vehicle to make a naratriptan hydrochloride suspension that is pourable. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add enough of the Vehicle to bring to final volume, and mix well.
ASSAY
• Procedure
Mobile phase:
2-propanol and 12 mM triethylamine phosphate buffer (1:10). Make adjustments if necessary.
Standard stock solution:
0.5 mg/mL of USP Naratriptan Hydrochloride RS in Mobile phase
Standard solution:
Transfer 1.0 mL of Standard stock solution to a 25-mL volumetric flask, dilute with Mobile phase to volume to obtain a solution containing 20 µg/mL of naratriptan hydrochloride, and pass through a suitable filter of 0.22-µm pore size.
Sample solution:
Shake the Oral Suspension thoroughly by hand. Pipet 0.4 mL into a 10-mL volumetric flask. Add 1 mL of 0.1 N sodium hydroxide solution by pipet, and sonicate for 5 min. Dilute with Mobile phase to volume, and mix to obtain a nominal concentration of 20 µg/mL of naratriptan hydrochloride. Centrifuge, and pass the naratriptan hydrochloride solution through a suitable filter of 0.22-µm pore size.
Chromatographic system
Mode:
LC
Detector:
UV 225 nm
Column:
4.6-mm × 25-cm; 5-µm packing L11
Flow rate:
1.4 mL/min
Injection size:
25 µL
System suitability
Sample:
Standard solution
Suitability requirements
Retention time:
9.7 min for the naratriptan peak
Relative standard deviation:
NMT 4.9% for the replicate injections
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of the labeled amount of (C17H25N3O2S·HCl) in the volume 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 naratriptan hydrochloride in the Standard solution (µg/mL), on the anhydrous basis |
| CU | = | = nominal concentration of naratriptan hydrochloride in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 791:
4.0–4.5
791:
4.0–4.5
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Package in tight, light-resistant containers. Store at controlled room temperature or controlled cold temperature.
• Labeling:
Label it to state that it is to be well shaken before use, and to state the Beyond-Use Date.
• Beyond-Use Date:
NMT 7 days after the date on which it was compounded when stored at controlled room temperature, and NMT 90 days after the date on which it was compounded if stored at controlled cold temperature.
• USP Reference Standards 11
11
USP Naratriptan 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 | Jeanne H. Sun
Assistant Scientific Liaison 1-301-816-3361 |
(CMP2010) Compounding |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4001
Pharmacopeial Forum: Volume No. 35(1) Page 90