Naratriptan Hydrochloride Oral Suspension
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 CompoundingNonsterile 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 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.
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.
Detector: UV 225 nm
Column: 4.6-mm × 25-cm; 5-µm packing L11
Flow rate: 1.4 mL/min
Injection size: 25 µL
Sample: Standard solution
Retention time: 9.7 min for the naratriptan peak
Relative standard deviation: NMT 4.9% for the replicate injections
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
Acceptance criteria: 90.0%110.0%
• pH 791: 4.04.5
• 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
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USP35NF30 Page 4001Pharmacopeial Forum: Volume No. 35(1) Page 90