フェキソフェナジン塩酸塩（日本薬局方記載条件）
Fexofenadine Hydrochloride (The Japanese Pharmacopoeia)

F130218AA) Standard solution*1(0.001 mg/mL Fexofenadine hydrochloride)
Systemsuitability
requirement

resultTheoretical plate number(Fexofenadine)

≧8000

10100

Tailing factor(Fexofenadine)≦2.0

1.00mAU
431210F130213C

0102030B) Sample solution*1(1 mg/mL Fexofenadine hydrochloride)

4050min

1OHHOHN

1CH3mAUO

4H3 C3・HClOH

Fexofenadine hydrochloride

210F130213D0ColumnEluent

1020304050min: YMC-Triart Phenyl (5 µm, 12 nm)
250 X 4.6 mmI.D.
: acetonitrile/buffer*2/triethylamine (350/650/3)*2 Dissolve 7.51 g of NaH2PO4･2H2O and 0.96 g of NaClO4･H2O in 1000 mL water,
adjust pH 2.0 with H3PO4

Flow rate: 2.0 mL/min (adjust the flow rate so that the retention time of fexofenadine is about 9 min)Temperature: 25℃Detection: UV at 220 nm
Injection: 20 µL(The Japanese Pharmacopoeia 16th; Related substances)*1 All standard and sample solutions were prepared from Fexofenadine hydrochloride supplied as a reagent forlaboratory use.

フェキソフェナジン塩酸塩（日本薬局方記載条件）
Fexofenadine Hydrochloride (The Japanese Pharmacopoeia)

Standard solution*1(0.06 mg/mL Fexofenadine hydrochloride)

F130213B

1OHH

OH

NmAU

CH3O・HClH3C120OH

Fexofenadine hydrochloride

100

180

60

40

Systemsuitability
requirement

resultTheoretical plate number(Fexofenadine)

≧8000

9500

Tailing factor (Fexofenadine)≦2.00.98

2000Column
Eluent2

468

1012141618min: YMC-Triart Phenyl (5 µm, 12 nm)
250 X 4.6 mmI.D.
: acetonitrile/buffer*2/triethylamine (350/650/3)*2 Dissolve 7.51 g of NaH2PO4･2H2O and 0.96 g of NaClO4･H2O in 1000 mL water,
adjust pH 2.0 with H3PO4

Flow rate: 2.0 mL/min (adjust the flow rate so that the retention time of fexofenadine is about 9 min)Temperature: 25℃
Detection: UV at 220 nm
Injection: 20 µL(The Japanese Pharmacopoeia 16th; Assay)*1 Standard solution was prepared from Fexofenadine hydrochloride supplied as a reagent for laboratory use.

フェキソフェナジン塩酸塩 （米国薬局方記載条件）
Fexofenadine Hydrochloride (The United States Pharmacopeia)

F130218BA) Assay preparation*1 (Assay), Reference solution*1 (Related compounds)(0.06 mg/mL Fexofenadine hydrochloride)mAU
120

1Systemsuitabilityrequirement(Assay)

result≦2.0

1.00

Tailing factor(Fexofenadine)80400F130213E

0246810B) Test solution*1 (Related compounds)(1 mg/mL Fexofenadine hydrochloride)

121416min

181OH
H

1OH

N

mAU

CH34O・HCl

H3C3OH

2Fexofenadine hydrochloride

10F130213F

0Column
Eluent1020304050min: YMC-Triart Phenyl (5 µm, 12 nm)
250 X 4.6 mmI.D.
: acetonitrile/buffer*2/triethylamine (350/650/3)*2 Dissolve 7.51 g of NaH2PO4･2H2O and 0.96 g of NaClO4･H2O in 1000 mL water,adjust pH 2.0 with H3PO4.

Flow rate: 1.5 mL/min
Temperature: 25℃
Detection: UV at 220 nm
Injection: 20 µL(The United States Pharmacopeia 36th; Assay, Related compounds)*1 All standard and sample solutions were prepared from Fexofenadine hydrochloride supplied as a reagent forlaboratory use.

フェキソフェナジン塩酸塩錠（日本薬局方記載条件）
Fexofenadine Hydrochloride Tablets (The Japanese Pharmacopoeia)
F130218CA) Standard solution*1(0.018 mg/mL Fexofenadine hydrochloride)
1mAU
80

Systemsuitability
requirement

result60

Theoretical plate number(Fexofenadine)

≧7000

12400

40Tailing factor (Fexofenadine)≦2.00.95

200F130215E

0123456789min

1B) Sample solution*2(0.018 mg/mL Fexofenadine hydrochloride)

OHmAU

H

1OH

N

80

CH3O60・HClH 3C
OH

4020Fexofenadine hydrochloride

0F130215B

0Column
Eluent123456789min: YMC-Triart Phenyl (5 µm, 12 nm)
250 X 4.6 mmI.D.
: acetonitrile/buffer*3 (9/16)*3 Add 15 mL of acetonitrile/triethylamine (1/1) to 1000 mL of acetic acid/water (17/9983),
adjust pH 5.25 with H3PO4Flow rate
: 1.1 mL/min (adjust the flow rate so that the retention time of fexofenadine is about 6 min)Temperature: 35℃
Detection: UV at 220 nm
Injection: 20 µL(The Japanese Pharmacopoeia 16th SupplementⅠ; Assay)*1 Standard solution was prepared from Fexofenadine hydrochloride supplied as a reagent for laboratory use.
*2 Sample solution was prepared from Fexofenadine hydrochloride tablets.

フェキソフェナジン塩酸塩錠（米国薬局方記載条件）
Fexofenadine Hydrochloride Tablets (The United States Pharmacopeia)
F130218DA) Standard solution*1(0.015 mg/mL Fexofenadine hydrochloride)
mAU
80

160
Tailing factor(Fexofenadine)

40Systemsuitability
requirement

result≦2.00.95

200F130215C

0123456789min

1B) Sample solution*2(0.018 mg/mL Fexofenadine hydrochloride)

OHmAU

H

180

OHN
CH3
O60・HClH 3COH

40

Fexofenadine hydrochloride

200F130215D01Column
Eluent23456789min: YMC-Triart Phenyl (5 µm, 12 nm)
250 X 4.6 mmI.D.
: acetonitrile/buffer*3 (9/16)*3 Add 15 mL of acetonitrile/triethylamine (1/1) to 1000 mL of acetic acid/water (17/9983),
adjust pH 5.25 with H3PO4Flow rate
: 1.5 mL/min
Temperature: 35℃
Detection: UV at 220 nm
Injection: 20 µL(The United States Pharmacopeia 36th; Assay)*1 Standard solution was prepared from Fexofenadine hydrochloride supplied as a reagent for laboratory use.
*2 Sample solution was prepared from Fexofenadine hydrochloride tablets.