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Table 4 Robustness assessment of the investigated methods for determination of IBU, PAP, PAR, PNP, CHZ and PCA

From: Impurity profiling of paracetamol toxic impurities in pharmaceutical combination with ibuprofen and chlorzoxazone using HPLC and TLC densitometric methods

 

TLC-Densitometric method

HPLC method

IBU

PAP

PAR

PNP

CHZ

PCA

 

PAP

PAR

PNP

IBU

CHZ

PCA

RSD%a

 

RSD%a

Saturation time

60 ± 5 min

Acetonitrile (%)

30 ± 2%

 Rsb

1.6

1.4

1.1

1.5

1.4

    Rsb

1.5

1.5

1.0

1.2

0.9

 RF

1.6

1.5

1.2

1.8

1.6

1.5

    tR

1.6

1.2

1.6

1.9

1.2

1.4

 K’

1.2

1.9

1.9

1.8

1.4

1.6

    K’

1.4

1.6

1.2

1.7

1.4

1.9

 T

1.2

0.9

1.2

0.9

1.4

1.1

    T

1.9

1.6

1.4

1.6

1.5

1.5

 R%

1.9

1.7

1.8

1.5

1.8

1.7

    R%

1.2

1.3

1.2

1.5

1.2

1.5

Ammonia content

0.2 ± 0.05 mL

Phosphate buffer pH

7.5 ± 0.5

 Rsb

1.7

1.6

1.3

1.5

1.8

    Rsb

1.8

1.0

1.2

1.2

0.9

 RF

1.7

1.5

1.2

1.8

0.9

1.7

    tR

1.6

1.5

1.7

1.2

1.7

1.5

 K’

1.6

1.6

1.9

1.7

1.5

1.9

    K’

1.5

1.6

1.2

1.7

1.7

1.9

 T

1.2

1.4

1.0

1.1

1.1

0.9

    T

1.7

1.5

1.9

1.8

1.5

1.9

 R%

1.6

1.6

1.4

1.9

1.5

1.7

    R%

1.5

1.8

1.6

1.4

1.5

1.4

Detector wavelength

220.0 ± 5.0 nm

Flow rate

0.7 ± 0.2 mL/min

 Rsb

1.8

1.8

1.7

1.8

1.7

    Rsb

1.7

1.4

1.4

1.2

1.3

 RF

1.7

1.5

1.2

1.9

1.6

1.5

    tR

1.3

1.5

1.7

1.3

1.3

1.5

 K’

1.4

1.4

1.4

1.7

1.7

1.5

    K’

1.2

1.6

1.2

1.0

1.4

1.2

 T

1.1

1.4

1.2

1.5

1.1

0.9

    T

1.9

1.6

1.4

1.6

1.5

1.7

 R%

1.6

1.7

1.6

1.6

1.5

1.8

    R%

1.4

1.4

1.8

1.7

1.3

1.8

  1. a RSD% for each system suitability parameter at the three specified conditions
  2. b Resolution is determined between each peak and the one preceding it