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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.