Aniracetam Capsules Assay (HPLC) following Chinese Pharmacopeia 2015 Monograph Method on Chromolith® HighResolution RP-18 endcapped with UV Detection

CONDITIONS
column
Chromolith® HighResolution RP-18 endcapped 150x4.6 mm 1.52023.0001 (1.52023.0001)
mobile phase
[A] water; [B] acetonitrile; (65:35, A:B)
flow rate
1.5 mL/min
pressure
1813 psi (125 bar)
column temp.
25 °C
detector
283 nm UV (analytical flow cell; (1μL/10mm)
injection
10 μL
Description
Analysis Note
LC-UV Analysis of Aniracetam Capsules (Huilaxitan Jiaonang). Aniracetam, or N-anisoyl-2-pyrrolidinone, is a nootropic agent (substance that improve cognitive function). It is as a prescription drug world-wide, but not approved for use in the United States. The performance criteria per the Chinese pharmacopeia (ChP) 2015 monograph method are met. The detection limit (LOD) and limit of quantitation (LOQ) with HPLC-UV are both better than 1 ppm.
Other Notes
SST Solution: Dissolve 50 mg of Aniracetam with 5 mL methanol into colorimeter tube, heat in water bath at 70 °C for 1h. Cool down to room temperature. Dilute with mobile phase to 1 mg/mL solution.
Standard solution: Dissolve appropriate amount of Aniracetam to mobile phase to obtain 80 μg/mL (80 ppm) standard solution.
Test solution: Take appropriate amount of drug powder from capsules into mobile phase to obtain 80 μg/mL (80 ppm) sample solution. Filter sample solution prior to injection through a 0.45 μm Millex™ PVDF filter.
Legal Information
Chromolith is a registered trademark of Merck KGaA, Darmstadt, Germany
Millex is a trademark of Merck KGaA, Darmstadt, Germany