Alprazolam Oral Suspension
Alprazolam Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of alprazolam (C17H13ClN4).
Prepare Alprazolam Oral Suspension 1 mg/mL as follows (see Pharmaceutical CompoundingNonsterile Solutions 795).
Comminute tablets in a suitable mortar to a fine powder, or add Alprazolam powder. Add about 20 mL of the Vehicle, and mix to a uniform paste. Add the Vehicle in small portions almost to volume, and mix 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.
Buffer: 0.04 M sodium acetate solution. Adjust with glacial acetic acid to a pH of 2.4.
Mobile phase: Methanol, acetonitrile, and Buffer (45:8:47)
Standard solution: 20 µg/mL of USP Alprazolam RS in Mobile phase
Sample solution: Agitate the container of Oral Suspension for 30 min on a rotating mixer, remove a 5-mL sample, and store in a clear glass vial at 70 until analyzed. At the time of analysis, remove the sample from the freezer, allow it to reach room temperature, and mix with a vortex mixer for 30 s. Dilute a suitable volume of the Oral Suspension in Mobile phase to obtain a nominal concentration of 20 µg/mL.
Detector: UV 230 nm
Column: 4.6-mm × 25-cm; 5-µm packing L1
Flow rate: 0.6 mL/min
Injection size: 20 µL
Sample: Standard solution
[NoteThe retention time of alprazolam is about 10 min. ]
Relative standard deviation: NMT 1.4% for replicate injections
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of alprazolam (C17H13ClN4) in the portion of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 90.0%110.0%
• pH 791: 4.05.0
• Packaging and Storage: Package in tight, light-resistant containers. Store at controlled room temperature, or under refrigeration.
• 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 60 days after the day on which it was compounded
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2103Pharmacopeial Forum: Volume No. 32(1) Page 46