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Table 2 Assay validation parameters of the proposed RP-HPLC and TLC methods

From: Green chromatographic methods for determination of co-formulated lidocaine hydrochloride and miconazole nitrate along with an endocrine disruptor preservative and potential impurity

Parameter

RP-HPLC

TLC

LDC

MIC

MTP

DMA

LDC

MIC

Linearity

 Range

2.00–100.00 µg/mL

1.00–100.00 µg/mL

1.00–20.00 µg/mL

1.00–20.00 µg/mL

0.30–3.00 µg/band

0.30–3.00 µg/band

 Intercept

46.441

4.4143

−1.4165

65.621

349.67

1217.5

 Slope

64.967

66.568

89

125.33

1120.5

4718

 Correlation coefficient (r)

0.9999

0.9999

0.9999

1

1

1

Precision(± %RSD)

 Repeatabiliya

0.881

0.869

0.50

1.133

0.862

1.228

 Intermediate precisionb

1.193

1.067

0.531

1.23

1.866

1.72

 Accuracyc

Mean

% RSD

101.04

0.782

101.31

0.936

99.62

1.371

99.91

1.302

101.1

1.658

100.72

0.667

 Specificityd

Mean

% RSD

100.16

1.078

100.37

1.71

99.91

0.856

99.73

0.84

99.63

0.964

100.1

0.547

 LODe

–

–

0.231

0.084

–

–

 LOQe

–

–

0.70

0.255

–

–

 Robustness parameterf (%RSD)

1.054

1.247

1.28

1.423

0.765

1.427

  1. aRepeatability was calculated as %RSD of three different concentrations of LDC and MIC within the same day for TLC method and three different concentrations of MIC, LDC, MTP and DMA for RP-HPLC method
  2. b Intermediate precision replication of the same concentrations of the examined drugs was carried out on 3 successive days and %RSD values were calculated
  3. c Accuracy was tested by calculating the average recovery of Three pure samples for LDC and MIC for TLC and Five pure samples for MIC, LDC, MTP and DMA for RP-HPLC method in triplicates
  4. d Specificity was tested by calculating average determinations of mixtures containing LDC and MIC for TLC method and the two drugs, MTP and DMA for RP-HPLC method in various ratios
  5. e LOD and LOQ were calculated from the standard deviation (s) of the regression residuals and the slope of the calibration curve (S) according to the following equations: LOD = 3.3(s/S) and LOQ = 10(s/S)
  6. f The Robustness for TLC method, it is assessed by applying small changes in the wavelength by 1 nm and saturation time ± 5 min. While for HPLC method, small changes in the ratio of pH by 0.05, flow rate ± 0.05 mL /min and the change in wavelength (210 ± 1 nm) are applied and %RSD values were calculated