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Table 2 Validation parameters for olopatadine hydrochloride

From: ICH guideline practice: application of novel RP-HPLC-DAD method for determination of olopatadine hydrochloride in pharmaceutical products

Parameters Values a± SD, ± %RSD
Linearity 1 to 20 μg/mL
  Regression equation AUC = 79,991X − 64,340
  Correlation coefficient r2 = 0.999 ± 0.001, ±0.100
Range 5 to 15 μg/mL ± 1.08, ±0.51
Accuracy 100.11 ± 1.065, ±0.784
Precision  
  Repeatability 99.94 ± 0.742, ±0.482
  Intermediate precision  
  Inter-day 100.08 ± 0.825, ±0.091
  Analyst to analyst 99.89 ± 0.929, ±0.027
Robustness  
  Temperature (20°C, 25°C and 30°C) 99.91 ± 0.816, ±0.089
  Formic acid concentration (±5%) 100.06 ± 0.794, ±0.296
LOQ 5 ng/mL ± 1.098, ±0.566
LOD 0.5 ng/mL ± 1.691, ±0.295
Specificity Ascertained by analysing standard drug and degraded sample of equivalent concentration
  1. aMean of six replicates. SD standard deviation, RSD relative standard deviation, AUC area under the curve, LOQ limit of quantification, LOD limit of detection.