オロパタジン塩酸塩（日本薬局方収載原案記載条件）
Olopatadine hydrochloride (The draft for the Japanese Pharmacopoeia)

U120724AA) Standard solution*1(0.005 mg/mL Olopatadine HCl)
System suitability
requirement

ResultTheoretical plate number(Olopatadine)

≧8000

18100

Tailing factor(Olopatadine)

≦2.0

1.08

Relative standard
deviation of the peak area(Olopatadine)

≦1.0%

0.07%

mAU

4.0

1
3.0

2.0

1.0

0.0
U120629C
0.0

5.0

10.0

15.0

20.0min

1B) Sample solution*1(0.5 mg/mL Olopatadine HCl)OmAU1O300

HO200

H3CN・HCl

CH3100Olopatadine hydrochloride0U120629B
0.0ColumnEluent

5.0

10.0

15.0

20.0min: YMC-Triart C8 (5 µm, 12 nm)
250 X 4.6 mmI.D.
: phosphate buffer (pH 3.5)*2/acetonitrile (11/9) containing 8 mM sodium lauryl sulfate2* Dissolve 8.6 g of KH2PO4 in 1000 mL of water, adjust pH 3.5 with H3PO4 (49→10000)

Flow rate
Temperature
Detection
Injection: 1.1 mL/min (adjust the flow rate so that the retention time of olopatadine is about 11 min)
: 40℃
: UV at 299 nm: 20 µL(The draft for the Japanese Pharmacopoeia; Related substances)
1* All standard and sample solutions were prepared from Olopatadine hydrochloride supplied as a reagent for laboratory use.

オロパタジン塩酸塩錠（日本薬局方収載原案記載条件）
Olopatadine hydrochloride tablets (The draft for the Japanese Pharmacopoeia)
1

U120724B

2OOOA) Assay: Standard solution*1(0.05 mg/mL Olopatadine HCl, 0.035 mg/mL Doxepine HCl)HO
H3C

H3C・HClN・HClN
CH3

CH3mAU
45

Olopatadine hydrochloride

Doxepine hydrochloride (I.S.)

40

135

System suitability
requirement

ResultResolution (1, 2)≧1320.5

Relative standard
deviation of the peak area
ratio of 1 to 2

≦1.0%

0.07%

3025220151050U120720A
0.05.010.0

15.020.0min

B) Dissolution: Standard solution*1(0.0028 mg/mL Olopatadine HCl)mAU
9System suitability
requirement

ResultTheoretical plate number(Olopatadine)≧1000018700

Tailing factor(Olopatadine)

≦2.0

1.08

Relative standard
deviation of the peak area
(Olopatadine)

≦1.5%

0.07%

876

15432
10U120702A
0.0

2.5ColumnEluent

5.0

7.5

10.0

12.5min: YMC-Triart C8 (5 µm, 12 nm)
250 X 4.6 mmI.D.
: phosphate buffer (pH 3.5)*2/acetonitrile (11/9) containing 8 mM sodium lauryl sulfate2* Dissolve 8.6 g of KH2PO4 in 1000 mL of water, adjust pH 3.5 with H3PO4 (49→10000)

Flow rate: 1.1 mL/min (adjust the flow rate so that the retention time of olopatadine is about 11 min)Temperature: 40℃

Detection: UV at 299 nm

Injection: 20 µL(The draft for the Japanese Pharmacopoeia; Assay, Dissolution)
1* All standard solutions were prepared from Olopatadine hydrochloride supplied as a reagent for laboratory use.

オロパタジン塩酸塩点眼薬（米国薬局方記載条件）
Olopatadine hydrochloride ophthalmic solution (The United States Pharmacopeia)

U120706CA) Standard solution*1(0.1 mg/mL Olopatadine HCl)mAU

System suitability
requirement

ResultTheoretical plate number(Olopatadine)

≧2000

6700

Tailing factor(Olopatadine)

≦2.0

1.43

Relative standard
deviation of the peak area(Olopatadine)

≦2.0%

0.26%

11008060

40

200

U120705A
0.0

2.5

5.0

7.5

10.0

12.5

15.0

17.5minB) Sample solution*1(0.1 mg/mL Olopatadine HCl)

1OOmAU1100

HOH3C80N・HClCH360

Olopatadine hydrochloride
40200
U120705B
0.0

2.5

5.0

7.5

10.0

12.5

15.0

17.5minColumn: YMC-Triart C8 (5 µm, 12 nm)

Eluent

150 X 4.6 mmI.D.
: phosphate buffer (pH 3.0)*2/acetonitrile (18/7)
2* Dissolve 13.6 g of KH2PO4 in 1000 mL of water, add 1 mL triethylamine, adjust pH 3.0 with H3PO4Flow rate

: 1.0 mL/min

Temperature: 25℃

Detection: UV at 299 nm

Injection: 30 µL(The United States Pharmacopeia 34th; Assay)
1* Standard solution was prepared from Olopatadine hydrochloride supplied as a reagent for laboratory use.
Sample solution was prepared from Olopatadine hydrochloride ophthalmic solution.