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Table 1 System suitability parameters for TAP

From: ICH guideline practice: application of validated RP-HPLC-DAD method for determination of tapentadol hydrochloride in dosage form

Parameters

Value for TAP a

SD

%RSD

Number of theoretical plates

21,930

61.64

0.281

Tailing factor

1.12

0.051

0.956

Capacity factor

16.44

0.222

1.352

RT (min)

5.34

0.037

0.698

Peak purity

1.00

0.000

0.000

  1. RT retention time, SD standard deviation, %RSD percentage of relative standard deviation. aMean of six values.