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Table 3 Analysis of olopatadine hydrochloride in pharmaceutical products

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

  Concentration of quality control samples (%)
Batch Raw material (μg/mL) Tablet (μg/mL) Eye drop (μg/mL)
  5 10 15 5 10 15 5 10 15
A 100.23 100.92 99.83 99.93 99.99 100.19 100.83 99.48 100.03
B 101.02 99.28 100.12 98.99 99.63 99.92 100.41 100.69 100.28
C 99.36 100.04 99.94 100.29 100.59 100.46 99.98 100.83 99.56
D 98.94 100.91 100.46 100.06 100.48 100.56 99.74 99.93 99.09
E 100.32 99.76 99.83 99.89 99.67 99.89 100.46 100.91 100.06
F 100.19 99.89 100.11 100.56 100.16 100.15 100.29 100.02 100.04
Mean 100.01 100.13 100.05 99.95 100.09 100.20 100.29 100.31 99.84
SD 0.556 0.404 0.498
  1. SD standard deviation.