技术
HPLC: suitable
试验参数
column: Ascentis® C18, 15 cm x 4.6 mm, 5 μm particles (581324-U)
mobile phase: [A} water; [B] acetonitrile, (65:35, A:B)
flow rate: 1.0 mL/min
pressure: 1305 psi (90 bar)
column temp.: 25 °C
injection: 10 μL
sample: SST Solution
适用性
application for HPLC
应用
pharmaceutical (small molecule)
分析说明
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.
其他说明
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.
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.
法律信息
Ascentis is a registered trademark of Merck KGaA, Darmstadt, Germany
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