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Table 5 Summary of regression, validation, and in-house tablet assay parameters for proposed RP-HPLC-PDA method

From: Design of experiment avenue for development and validation of RP-HPLC-PDA method for determination of apremilast in bulk and in in-house tablet formulation

Validation parameters

Results

Regression coefficient

0.998

Slope

13583

Intercept

10304x

Linearity range (μg/ml)

2–12

Intra-day precision (n = 3, RSD, %)

0.15–0.77

Inter-day precision (n = 3, RSD, %)

0.17–0.98

Repeatability (n = 3, RSD, %)

1.66

Accuracy

99.44–100.49

  DL (μg)

0.015

  QL (μg)

0.41

Ruggedness

  Analysts I (n = 3, RSD, %)

1.59

  Analysts II (n = 3, RSD, %)

1.27

Robustness

Robust

Specificity

Specific

In-house tablet assay

98.85 ± 0.13

  1. n number of determinations