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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