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Acetaminophen
Drug Substance by HPLC
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printable Application Sheet
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Note: Acetaminophen (n-acetyl-p-aminophenol, APAP) is an anti-inflammatory valuable drug (nonsteroidal). The drug is widely
used for the management of pain and fever. Safety concerns require analyzing the composition of the pharmaceutical
formulations. The proposed method can be used for the routine quality control of acetaminophen.
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Method Conditions
| Column |
Cogent Bidentate™, 4µm, 100A |
| Catalog No. |
40018-75P |
| Dimensions |
4.6 x 75 mm |
| Mobile Phase |
| Solvent A: |
100% DI water + 0.1% acetic acid + 0.005% TFA |
| Solvent B: |
100% acetonitrile + 0.1% acetic acid + 0.005% TFA |
Gradient:
| Time |
%B |
Time |
%B |
| 0.0 |
0 |
6.0 |
30 |
| 1.0 |
0 |
6.01 |
0 |
| 4.0 |
30 |
10.0 |
0 |
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| Flow rate |
1.0 mL/minute |
| Peaks |
1: Impurity
2: Acetaminophen
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| Injection Volume |
2 µL |
| Sample |
1 mg of the compound dissolved in 1 mL of 50% A/50%B solution. Sample for injection diluted 1:15 with 100% A.
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| Detection |
UV 254 nm |
Discussion
A high-performance liquid chromatography (RP-HPLC) method has been developed for determination of acetaminophen: drug substance.
The chromatographic separation was achieved on a Cogent Bidentate™ C-18 column using a gradient elution. The method shown
here has excellent stability and reproducibility (RT of acetaminophen for 5 consecutive injections were; 4.122, 4.122, 4.121, 4.119,
4.121 min: 0.03% RSD).
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