Acetaminophen Impurity Analysis by HPLC Using a Bidentate C18 Column - AppNote
January 28, 2021
/
/
/
Date: 28-JANUARY-2021 Last Updated: 30-AUGUST-2026
Acetaminophen - Alternate USP MethodAcetaminophen and two of its major impurities were analyzed using a simple Mobile Phase. The Peak Shapes are very good and the Repeatability was good (%RSD = 0.01).
Peaks:
1. 4-Aminophenol
1.072 minutes
2. Acetaminophen
4.668 minutes
3. 4-nitrophenol
7.588 minutes
Column: Cogent Bidentate C18™, 4 µm, 100Å
Catalog No.: 40018-75P
Dimensions: 4.6 x 75 mm
Mobile Phase:
-- A: DI Water with 0.1% Formic Acid
-- B: Acetonitrile with 0.1% Formic Acid
Gradient:
| Time (minutes) | %B |
|---|---|
| 0 | 0 |
| 1 | 0 |
| 4 | 30 |
| 6 | 30 |
| 6.01 | 10 |
| 10 | 10 |
Post Time: 3 minutes
Injection Volume: 5 µL
Flow Rate: 1.0 mL / minute
Detection: UV
-- 280 nm (4-aminophenol, acetaminophen)
-- 324 nm (4-nitrophenol)
Sample Preparation: The stock solution was prepared by dissolving 1.0 mg of standards in 10.00 mL of the Mobile Phase (50:50 Solvent A / Solvent B). The Solution was then filtered with a 0.45 µm Nylon Syringe Filter. The injection sample was diluted 1:10.
t 0 : 0.9 minutes.
Note : Acetaminophen (n-acetyl-p- aminophenol, APAP) is a non-steroid anti- inflammatory drug. There are several impurities that can be present in a final drug (depending on the synthetic route, the quality of starting materials, reagents, etc.) which can have safety implications. Analytical methods are needed
to detect and identify these impurities and quantify them.
