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

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

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