Naratriptan Compounded Oral Suspension

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Naratriptan Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of naratriptan (C₁₇H₂₅N₃O₂S). Prepare Naratriptan Compounded Oral Suspension containing 0.5 mg/mL of Naratriptan as follows (see Pharmaceutical Compounding-Nonsterile Preparations (795)).

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 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.

2 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. Centrifuge, and pass the naratriptan solution through a suitable filter of 0.22-µm pore size.

Chromatographic system

(See Chromatography (621). System Suitability.)

Mode: LC

Detector: UV 225 nm

Column: 4.6-mm x 25-cm; 5-µm packing L11

Injection volume: 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 naratriptan (C₁₇H₂₅N₃O₂S) in the portion of Oral Suspension taken:

                         Result = (r_U/r_S) × (C_S/C_U) × (M_r1/M_r2) ×100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution 

C_S = concentration of USP Naratriptan Hydrochloride RS in the Standard solution (µg/mL), on the anhydrous basis

C_U = nominal concentration of naratriptan in the Sample solution (µg/mL)

M_r1 = molecular weight of naratriptan, 335.47

M_r2 = molecular weight of naratriptan hydrochloride, 371.93

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

PH (791): 4.0-4.5

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in tight, light-resistant containers. Store at controlled room temperature or in a refrigerator.

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 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 Naratriptan Hydrochloride RS