グリメピリド(日本薬局方収載原案記載条件;(日本薬局方収載原案記載条件;類縁物質)類縁物質)
グリメピリド疎水性の異なるC18カラムによる比較
疎水性の異なるC18カラムによる比較

U101216A

J’sphere ODS-M80 (標準タイプ C18)
mAU

1.5
Glimepiride

1.0

Flow rate : 1.0 mL/min
Pressuer : 16.3 MPa

0.50U101122B

0510152025303540min

J’sphere ODS-L80 (低疎水性タイプ C18)
mAU

1.5

Glimepiride
1.0

Flow rate : 0.8 mL/min
Pressuer : 12.3 MPa

0.50U101115A

010OOONNH

Glimepirideminresult

Systemsuitability
requirement

J’sphereODS-M80

J’sphereODS-L80Theoretical plate number(Glimepiride)

≧9000

24600

21300

Tailing factor(Glimepiride)

≦1.5

1.04

1.10

NH

H3C

ColumnEluent

40

CH3NH

H3C30OSO

20: 250 X 4.0 mmI.D. (4 µm, 8 nm): phosphate buffer (pH 2.5)/acetonitrile (50/50)
phosphate buffer : dissolve 0.5 g of NaH2PO4 in 500 mL water and adjust pH 2.5 with H3PO4Flow rate

: adjust the flow rate so that the retention time of Glimepiride is about 17 min

Temperature : 25℃
Detection: UV at 228 nm

Injection: 20 µL

Sample: Glimepiride* (0.0002 mg/mL, correspond to standard solution)* A reagent for laboratory use
YMC Co., Ltd.

http://www.ymc.co.jp

グリメピリド(日本薬局方収載原案記載条件;(日本薬局方収載原案記載条件;定量法)
定量法)
グリメピリド疎水性の異なるC18カラムによる比較
疎水性の異なるC18カラムによる比較

U101215A

J’sphere ODS-M80 (標準タイプ C18)mAU
Glimepiride

800
600
400

Flow rate : 1.0 mL/min
Pressuer : 16.3 MPa

2000U101122A

010203040min

J’sphere ODS-L80 (低疎水性タイプ C18)mAU
Glimepiride
800
600
400

Flow rate : 0.8 mL/min
Pressuer : 12.3 MPa

2000U101112A

010OOOSON20Column
Eluent

40

CH3O

NH

Glimepiride

minresult

Systemsuitability
requirement

J’sphere
ODS-M80

J’sphereODS-L80

Theoretical plate number(Glimepiride)

≧9000

20400

18400

Tailing factor(Glimepiride)

≦1.5

0.98

1.12

NH

NH

H3C
H3C

30

: 250 X 4.0 mmI.D. (4 µm, 8 nm): phosphate buffer (pH 2.5)/acetonitrile (50/50)
phosphate buffer : dissolve 0.5 g of NaH2PO4 in 500 mL water and adjust pH 2.5 with H3PO4Flow rate

: adjust the flow rate so that the retention time of Glimepiride is about 17 min

Temperature : 25℃Detection: UV at 228 nm

Injection: 20 µL

Sample: Glimepiride* (0.2 mg/mL, correspond to standard solution)* A reagent for laboratory use
YMC Co., Ltd.

http://www.ymc.co.jp

グリメピリド錠
Glimepiride Tablets

U101222AA) Standard solution*(0.0018 mg/mL Glimepiride)mAU

4

3System suitability
requirement

resultTheoretical plate number(Glimepiride)

≧6000

9700

Tailing factor(Glimepiride)

≦1.5

1.02

Glimepiride

21U101221A

005

1015

2025minB) Sample solution*(0.18 mg/mL Glimepiride)mAUOOGlimepirideO250SONNHCH3ONHNH

H3C

200

H3C150Glimepiride

10050
U101220B

005ColumnEluent

10152025min: YMC-Triart C18 (5 µm, 12 nm)
125 X 4.0 mmI.D.
: phosphate buffer (pH 3.5)/acetonitrile (50/50)
phosphate buffer : dissolve 0.5 g of NaH2PO4 in 500 mL water and adjust
pH 3.5 with H3PO4 (1→5)

Flow rate: 0.75 mL/min
Temperature: 25℃
Detection: UV at 228 nm
Injection: 5 µL(The draft for the Japanese Pharmacopoeia; Related substances)* All standard and sample solutions were prepared from Glimepiride supplied as a reagent for laboratory use.

グリメピリド錠
Glimepiride Tablets

U101220A

1OmAU
O

CH3HO

175

Butyl p-hydroxybenzoate (I.S.)

150

212125

O

100

OO
SON

NH

CH3ONH

NH

H3C
H3C

75

Glimepiride

50

25

System suitability
requirement

result≧612.5Resolution (1, 2)

002

4Column
Eluent68101214 min: YMC-Triart C18 (5 µm, 12 nm)
125 X 4.0 mmI.D.
: phosphate buffer (pH 3.5)/acetonitrile (50/50)
phosphate buffer : dissolve 0.5 g of NaH2PO4 in 500 mL water and adjust
pH 3.5 with H3PO4 (1→5)

Flow rate
Temperature
Detection
Injection
Sample: 0.9 mL/min: 25℃: UV at 228 nm: 10 µL: 1. Butyl p-hydroxybenzoate (0.12 mg/mL)
2. Glimepiride* (0.06 mg/mL)(The draft for the Japanese Pharmacopoeia; Assay)* Glimepiride: A reagent for laboratory use