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Table 4 Assay validation of the proposed method for the determination of ETO, PCM, PAP, and PHA as per ICH guidelines

From: Validated HPLC–PDA methodology utilized for simultaneous determination of Etoricoxib and Paracetamol in the presence of Paracetamol toxic impurities

Parameters

Proposed HPLC method

ETO

PCM

PAP

PHA

Range (μg/mL)

1.5–30

1.5–30

0.5–10

0.5–10

Linearity

    

 Slope

263,046

189,792

204,882

231,325

 Intercept

50,255

934,351

112,694

25,478

 Correlation coefficient (r)

0.9999

0.9993

0.9996

0.9998

Accuracy a (Mean ± %SD)

100.21 ± 0.973

100.58 ± 0.858

98.17 ± 1.362

99.32 ± 1.163

Precision (%RSD)

    

 Repeatability b

0.942

1.388

1.361

1.270

 Intermediate c

1.344

1.422

1.588

1.454

 LOD (μg/mL) d

0.304

0.397

0.113

0.062

 LOQ (μg/mL) d

0.923

1.204

0.343

0.189

  1. a Accuracy (mean ± %RSD) [average of three different concentrations of three replicates each (n = 9)]
  2. b The intraday (n = 9), RSD % of three concentrations (10,15, 30 μg/mL) for ETO, PCM, and (3,5,10 μg/mL) for PAP, and PHA, respectively; repeated three times within the same day
  3. c The interday (n = 9), RSD % of three concentrations (10,15, 30 μg/mL) for ETO, PCM, and (3,5,10 μg/mL) for PAP, and PHA, respectively; repeated three times in three successive days
  4. d LOD and LOQ are calculated using the formula LOD = 3.3*(SD of intercept /slope) and, LOQ = 10*(SD of intercept /slope), respectively
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BMC Chemistry

ISSN: 2661-801X

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