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Table 1 Regression and validation data for the determination of SER.DMP and DMP by the proposed methods

From: Chromatographic reversed HPLC and TLC-densitometry methods for simultaneous determination of serdexmethylphenidate and dexmethylphenidate in presence of their degradation products—with computational assessment

Drug Name

SER.DMP

Parameters

HPLC method

TLC densitometric method

Wavelength (nm)

220 nm

220 nm

Linearity range

2.5— 25 (μg/mL)

5— 25 (μg/spot)

LOD

0.051(μg/mL)

0.184 (μg/spot)

LOQ

0.165 (μg/mL)

0.202 (μg/spot)

Regression Equation

y a = 0.0989 C b + 0.0331

y a = 0.0824 C b + 0.0216

 Correlation coefficient (r)

0.9998

0.9997

 Accuracy (% R) ± SD

100.43 ± 1.02

99.68 ± 1.03

Precision (% RSD)

 Repeatability c

1.021

1.025

 Intermediate precision d

1.015

1.039

Robustness (% RSD)

 Mobile phase contents ratio (± 2%)

0.812

1.386

 Detection wavelengths (± 2 nm)

1.349

1.526

 Flow rate (± 0.1 ml/min.)

1.778

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Drug Name

DMP

Parameters

HPLC method

TLC densitometric method

Wavelength (nm)

220 nm

220 nm

Linearity range

2.5–25 (μg/mL)

5–25 (μg/spot)

LOD

0.098 (μg/mL)

0.115 (μg/spot)

LOQ

0.186 (μg/mL)

0.237 (μg/spot)

Regression Equation

y a = 0.0897 C b + 0.0522

y a = 0.0905 C b + 0.0612

 Correlation coefficient (r)

0.9997

0.9996

 Accuracy (% R) ± SD

100.15 ± 1.1

99.50 ± 1.2

Precision (% RSD)

 Repeatability c

1.105

1.160

 Intermediate precision d

1.251

1.249

Robustness (% RSD)

 Mobile phase contents ratio (± 2%)

0.812

1.128

 Detection wavelengths (± 2 nm)

1.349

1.630

 Flow rate (± 0.1 ml/min.)

1.778

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  1. a Peak area of mixture of SER.DMP and DMP
  2. b Concentration in μg/ml for HPLC method and in μg/spot for TLC densitometric method
  3. c The intraday (n = 3), average of three concentrations of SER.DMP and DMP (10, 15 and
  4. 20 μg/mL) for HPLC method and (10,15 and 20 μg/spot) for TLC densitometric method
  5. repeated three times within the day
  6. d The interday (n = 3), average of three concentrations of SER.DMP and DMP (10,15
  7. and 20 μg/mL) for HPLC method and (10,15 and 20 μg/spot) for TLC densitometric
  8. method repeated three times in three days