Tiagabine Hydrochloride Oral Suspension
Tiagabine Hydrochloride Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled content of tiagabine hydrochloride (C20H25NO2S2·HCl). Prepare Tiagabine Hydrochloride Oral Suspension (1 mg/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 Tiagabine Hydrochloride powder. Add the Vehicle in small portions and triturate to make a smooth paste. Add increasing volumes of the Vehicle to make a tiagabine 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: Acetonitrile and 5 mM octanesulfonic acid (1:1). Pass through a suitable filter of 0.45-µm pore size and degas.
Standard stock solution: 1.0 mg/mL of USP Tiagabine Hydrochloride RS in methanol
Standard solution: Transfer 0.2 mL of Standard stock solution to a 10-mL volumetric flask, dilute with Mobile phase to volume to obtain a solution containing 20 µg/mL of tiagabine hydrochloride. Centrifuge, and pass through a suitable filter of 0.22-µm pore size.
Sample solution: Shake thoroughly by hand each bottle of Oral Suspension. Centrifuge, and pass through a suitable filter of 0.22-µm pore size. Accurately pipet 0.2 mL of the Oral Suspension to a 10-mL volumetric flask, and dilute with Mobile phase to volume to obtain a nominal concentration of 20 µg/mL of tiagabine hydrochloride.
Detector: UV 240 nm
Flow rate: 0.4 mL/min
Column: 3.0-mm × 15-cm; 5-µm packing L10
Injection size: 10 µL
Sample: Standard solution
[NoteThe retention time of the tiagabine peak is 3.2 min. ]
Relative standard deviation: NMT 1.7%
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of C20H25NO2S2·HCl in the volume of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 90.0%110.0% of the labeled amount of C20H25NO2S2·HCl
• 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 90 days after the date on which it was compounded, when stored at controlled cold temperature, or NMT 60 days after the date it was compounded, when stored at controlled room temperature.
• USP Reference Standards 11
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USP35NF30 Page 4858Pharmacopeial Forum: Volume No. 35(1) Page 98