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

Journal of Analytical Science and Technology

Table 2 Validation parameters for olopatadine hydrochloride

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

^aMean of six replicates. SD standard deviation, RSD relative standard deviation, AUC area under the curve, LOQ limit of quantification, LOD limit of detection.