アトルバスタチンカルシウム水和物
Atorvastatin calcium hydrate

R100421E

標準溶液 (0.01 mg/mL)
mAU

1

1H3 CONH

15CH3OH OH

N

F

10CO2-Ca2+・ 3H2O

2

Atorvastatin calcium hydrate
50R100517A
02550min2550min試料溶液 (1.0 mg/mL)
1mAU
10

50R100511C
0Column
EluentFlow rate
Temperature
Detection
Injection: YMC-Pack Pro C18 RS (5 mm, 8 nm)
250 X 4.6 mmI.D.
: A) citric acid buffer※/acetonitrile/THF (40/10/10)
B) acetonitrile/THF (1/1)
7%B (0-40 min), 7-40%B (40-80 min)※Dissolve 10.5 g citric acid monohydrate in 900 mL water→ adjust pH 5.0 by 28% ammonia → add water to make 1000 mL: 1.3 mL/min: 40℃: UV at 254 nm: 20 mL（日本薬局方収載原案記載条件; 純度試験）

アトルバスタチンカルシウム水和物 (日本薬局方収載原案記載条件； 純度試験)‑ 各種C18カラムとの比較‑
R100507A
YMC-Pack Pro C18 RSmAU

1. Atorvastatin calcium hydrate

1105

1.3 mL/min
17.2-15.3 MPa

0R100511C
0204060min

YMC-Triart C18mAU

11051.7 mL/min
18.2-15.8 MPa

0R100423E
0204060min

YMC-Pack ODS-AmAU

1105

1.4 mL/min
20.5-18.1 MPa

0R100422L
020Column
EluentTemperature
Detection
Injection

4060min: 250 X 4.6 mmI.D. (5 mm): A) citric acid buffer※/acetontrile/THF (40/10/10)
B) acetonitrile/THF (1/1)
7%B (0-40 min), 7-40%B (40-80 min)※Dissolve 10.5 g citric acid monohydrate in 900 mL water→ adjust pH 5.0 by 28% ammonia → add water to make 1000 mL: 40℃: UV at 254 nm: 20 mL (1.0 mg/mL)（日本薬局方収載原案記載条件; 純度試験）
YMC Co., Ltd.

http://www.ymc.co.jp

アトルバスタチンカルシウム水和物
Atorvastatin calcium hydrate

R100422H
1OO
HO

Butyl 4-hydroxybenzoate (I.S.)

2mAU

1600

2500

H3 CONH

CH3OH OHN

CO2-Ca2+・ 3H2O

400
F

300

2

Atorvastatin calcium hydrate

200

10000Column
EluentFlow rate
Temperature
Detection
Injection

510min: YMC-Pack Pro C18 RS (5 mm, 8 nm)
250 X 4.6 mmI.D.
: citric acid buffer※/acetontrile/THF (53/27/20)※Dissolve 10.5 g citric acid monohydrate in 900 mL water→ adjust pH 4.0 by 28% ammonia → add water to make 1000 mL: 1.2 mL/min: 40℃: UV at 254 nm: 10 mL (0.13, 0.4 mg/mL)（日本薬局方収載原案記載条件; 定量法）

アトルバスタチンカルシウム錠
Atorvastatin calcium tablets

R100518P

製剤均一性 (0.04 mg/mL, 0.11 mg/mL, 10 mL inj.)
250

1mAU

200

NO22

Rs (1, 2)=18.4

150

1NO2

100

1,3-Dinitrobenzene (I.S.)

50
020510min
NH

溶出性 (0.006 mg/mL, 50 mL inj.)
mAU

N(2) 14954
Tf(2) 1.1

5025H 3CO

R100518F-50CH3OH OHNCO2-F

2-25-50-75R100518E0510min

定量法 (0.04 mg/mL, 0.11 mg/mL, 10 mL inj.)
250

1mAU

2200
150

Rs (1, 2)=18.4

100500-50R100518G0Column
EluentFlow rate
Temperature
Detection

510min: YMC-Pack ODS-A (5 mm, 20 nm)
250 X 4.6 mmI.D.
: citric acid buffer※/acetonitrile/THF (53/27/20)※Dissolve 10.5 g citric acid monohydrate in 900 mL water→ adjust pH 4.0 by 28% ammonia → add water to make 1000 mL: 1.3 mL/min: 30℃: UV at 244 nm（日本薬局方収載原案記載条件）

2Atorvastatin calcium hydrate

0-100Ca2+・ 3H2O

アトルバスタチンカルシウム錠 (日本薬局方収載原案記載条件； 定量法)
‑ 各種C18カラムとの比較‑
YMC-Pack Pro C18 RS (8 nm)

1. 1,3-Dinitrobenzene (I.S.)
2. Atorvastatin calcium hydrate

1mAU

N(1) 19769
N(2) 13240
Rs (1, 2)=19.9

150
100R100521A

2

1.6 mL/min
21.3 MPa

500R100512I
0510min

YMC-Pack ODS-A (12 nm)
1mAU

200

N(1) 20083
N(2) 15477
Rs (1, 2)=21.2150
100

1.5 mL/min
22.2 MPa

2500-50R100517P
0510min

YMC-Pack ODS-A (20 nm)
250

1mAU

150
100

1.3 mL/min
14.0 MPa

2N(1) 18861
N(2) 14500
Rs (1, 2)=18.4

200

低圧で使用可能500-50R100518G
05Column
EluentTemperature
Detection
Injection

10min: 250 X 4.6 mmI.D. (5 mm): citric acid buffer※/acetonitrile/THF (53/27/20)※Dissolve 10.5 g citric acid monohydrate in 900 mL water→ adjust pH 4.0 by 28% ammonia → add water to make 1000 mL: 30℃: UV at 244 nm: 10 mL (0.04, 0.11 mg/mL)（日本薬局方収載原案記載条件; 定量法）
YMC Co., Ltd.

http://www.ymc.co.jp