Quinidine Sulfate Oral Suspension
Quinidine Sulfate Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of quinidine sulfate [(C20H24N2O2)2·H2SO4·2H2O]. Prepare Quinidine Sulfate Oral Suspension 10 mg/mL as follows (see Pharmaceutical CompoundingNonsterile Preparations 795).
If using Quinidine Sulfate Tablets, place in a suitable mortar, and comminute into a fine powder, or add Quinidine Sulfate powder to the mortar. Add 15 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 to the calibrated bottle. Add sufficient Vehicle to volume, and mix well.
Solution A: Add 35.0 mL of methanesulfonic acid to 20.0 mL of glacial acetic acid, and dilute with water to 500 mL.
Solution B: Dissolve 10.0 mL of diethylamine in water to obtain 100 mL of solution.
Mobile phase: Acetonitrile, Solution A, Solution B, and water (10:1:1:40)
Standard solution: 100 µg/mL of USP Quinidine Sulfate 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 on a vortex mixer for 30 s. Pipet 1.0 mL of the Sample solution into a 100-mL volumetric flask, and dilute with Mobile phase to volume.
Detector: UV 235 nm
Column: 4.6-mm × 25-cm; 5-µm packing L1
Flow rate: 1 mL/min
Injection size: 20 µL
Sample: Standard solution
[NoteThe retention time for quinidine sulfate is about 8.5 min. ]
Relative standard deviation: NMT 1.0%
Samples: Standard solution and Sample solution
Calculate the percentage of (C20H24N2O2)2·H2SO4·2H2O in the volume of Oral Suspension taken:
Result = 100 × (C/V) × (rb,U + rd,U)/(rb,S + rd,S)
Acceptance criteria: 90.0%110.0%
• pH 791: 3.44.4
• Packaging and Storage: Preserve in tight, light-resistant containers. Store at room temperature, or in a cold place.
• Beyond-Use Date: 60 days after the day on which it was compounded
• 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
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4506Pharmacopeial Forum: Volume No. 35(6) Page 1475