エソメプラゾールマグネシウム （米国薬局方記載条件）
Esomeprazole Magnesium (The United States Pharmacopeia)

AB200829A(A) Standard solution*¹(0.05 mg/mL Omeprazole)
1mAU

Systemsuitability
requirement

ResultTheoretical plate number(Omeprazole)

≧2000

9400

Relative standard deviationof the peak area (n=6)(Omeprazole)

≦2.0%

0.36%

250
200
150
10050
AB200414A06
00123456789min

1.
HN(B) Sample solution*¹(0.05 mg/mL Esomeprazole magnesium)

CH3
N

S
H3CO

2mAU

OCH3

H3C

NO

Omeprazole

200

2.
H3C

150

OCH3N

100
H3CON2+Mg

CH3SNO50

2

AB200414D03

Esomeprazole magnesium00123Column

456789min: YMC-Triart C8 (5 μm, 12 nm)
150 X 4.6 mmI.D.

Eluent: phosphate buffer (pH 7.6)*²/acetonitrile (13/7)*²Dissolve 4.472 g of Na2HPO4・2H2O and 0.725 g of NaH2PO4 in 1000 mL water, dilute 250 mLof this solution with water to 1000 mL and adjust pH 7.6 with H3PO4

Flow rate: 1.0 mL/min

Temperature: 25℃Detection: UV at 280 nm

Injection: 20 µL(The United States Pharmacopeia 42nd; ASSAY)*¹All standard and sample solutions were prepared from Omeprazole and Esomeprazole magnesium supplied
as a reagent for laboratory use.

エソメプラゾールマグネシウム （米国薬局方記載条件）
Esomeprazole Magnesium (The United States Pharmacopeia)

AB200830A(A) System suitability solution*¹(0.04 mg/mL Omeprazole related compound A, 0.04 mg/mL Omeprazole)
1mAU
250

Systemsuitability
requirement

Result≧3.0

5.4

Resolution (1, 2)

200
150

2

OCH 3

H3C

1.

100

HNCH3NS

50
H3CO

AB200709A130246810122.

OCH3H3CHN

3mAUOOOmeprazole related compound A(Omeprazole sulfone)

14 min(B) Sample solution*¹(0.16 mg/mL Esomeprazole magnesium)

NCH3N

S
H3CO500

NOOmeprazole

400

3.

300

H3C

OCH3N200
H3CO100

NNO
2AB200709B1302+Mg

CH3
S

Esomeprazole magnesium
2Column

468101214 min: YMC-Triart C8 (5 μm, 12 nm)
150 X 4.6 mmI.D.

Eluent: phosphate buffer (pH 7.6)*²/acetonitrile (29/11)*²Dissolve 4.472 g of Na2HPO4・2H2O and 0.725 g of NaH2PO4 in 1000 mL water, dilute 250 mLof this solution with water to 1000 mL and adjust pH 7.6 with H3PO4Flow rate

: 1.0 mL/min

Temperature: 45℃Detection: UV at 280 nmInjection: 50 µL(The United States Pharmacopeia 42nd; ORGANIC IMPURITIES)*¹All system suitability and sample solutions were prepared from Omeprazole related compound A, Omeprazole
and Esomeprazole magnesium supplied as a reagent for laboratory use.

リュープロレリン酢酸塩
Leuprorelin acetate (Leuprolide acetate)

AB200926A(A) Leuprorelin acetate (0.05 mg/mL)

NH2HNmAUNHOHN

15N
O10NH

OOHO

NHNHNNHONHONHONHOHNHONH

5OO
OH

0Leuprorelin acetate

AB200924A
1020304050607080min(B) Leuprolide acetate alkali degradation
mAU
25Method of alkali degradation

20Leuprorelin acetate(0.1 mg/mL)←1M NaOH

15100℃, 60 min

10←1M H3PO45analysis

0AB200924B
01020ColumnEluent

304050607080min: YMC-Triart Bio C18 (3 μm, 30 nm)
100 X 4.6 mmI.D.
: buffer (pH 3.0)*/acetonitrile/1-propanol (85/9/6)*Dissolve 15.2 g of triethylamine in 800 mL of water and adjust pH 3.0 with H3PO4, and add
water to make 1000 mL.

Flow rate
Temperature
Detection
Injection: 0.75 mL/min: 25℃: UV at 220 nm: 20 µL

Reference
The Japanese Pharmacopoeia 17th Edition, Leuprorelin Acetate / Official Monographs

NHO

ヒハツ（ロングペッパー）抽出物中のピペリン類
Piperine and the derivatives in long pepper extract

U201005A

21

0.0
0

0.5
0.5

1.0
1.0

1.5
1.5

1.

2.0
2.0

2.5
2.5

3.0
3.0

2.

5

3.5
3.5

4.0
4.0

O

OONO

4.5
4.5minmin

3.

OONOONO

Piperine

Piperanine4.

Chavicine

5.
OO

0.03 4O

0.5O

1.0N

1.5

2.0O

2.5

3.0O

Isopiperine

3.5

4.0

4.5minN

Isochavicine

Courtesy of T. Mizumoto, MARUZEN PHARMACEUTICALS CO., LTD.

Column: Meteoric Core C18 (2.7 µm, 8 nm)
100 X 4.6 mmI.D.
Eluent: A) acetonitrile/water/formic acid (450/550/1)
B) acetonitrile
0%B (0-5 min), 100%B (5.01-15 min), 0%B (15.01-25 min)Flow rate: 1.4 mL/min
Temperature : 35℃
Detection: UV at 270 nm
Injection: 20 µL
Sample: Long pepper extract powder
Reference:
T. Mizumoto, F. Nakano, Y. Nishizaki, N. Masumoto, N. Sugimoto,
Quantitative Analysis of Piperine and the Derivatives in Long Pepper Extract by HPLC Using Relative Molar Sensitivity,
Food Hygiene and Safety Science 60 (5) : 134-143 (2019)