IC Application Note No.

U-28
Title: Salicylic acid impurity in aspirin tablets
according to the USP method

Summary: Determination of salicylic acid and acetylsalicylic acid

according to USP 28-NF 23 (second supplement) using
RP chromatography with UV detection.

Sample: Aspirin (acetylsalicylic acid) standards

Sample Preparation: Aspirin and salicylic acid are dissolved in acetonitrile /
formic acid (99:1)

Column: 6.1008.100 Prontosil 120-5-C18 AQ 150

Wavelength: 280 nm
Eluent: 2 g/L sodium 1-heptanesulfonate in water / acetonitrile
(85:15), pH = 3.4 with glacial acetic acid
Flow: 2.0 mL/min
Injection Volume: 10 µL
mAU

100
Aspirin
90

80

70

60

50
Salicylic acid

40

30
1
20
2
10
Abs.1

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 min

Chromatogram: Salicylic acid Aspirin

(acetylsalicylic acid)
mg/mL mg/mL
0.3 1.0

U-28
Results:
Test factors Value Limit Result
Tailing factor 0.78 Less than 2 PASS
RSD Aspirin 1.5% Less than 2.0% PASS
RSD salicylic acid 1.3% Less than 4.0% PASS
Resolution 4.3 More than 2 PASS