ロサルタンカリウム
Losartan potassium

D111104A

Standard solution *(0.25 mg/mL Losartan potassium)

1CH3N
Cl

1mAU

N

HOK

40NNN
N

30

Losartan potassium

2010System suitability
requirement

ResultTheoretical plate number(Losartan potassium)

≧5600

13400

Tailing factor( Losartan potassium )

≦1.4

1.13

Relative standard deviationof the peak area(Losartan potassium)

≦0.5%

0.07%

00510Column: YMC-Triart C18 (5 µm, 12 nm)
250 X 4.0 mmI.D.

EluentFlow rate
Temperature
Detection
Injection: acetonitrile/0.1% phosphoric acid (40/60): 1.0 mL/min: 35℃: UV at 254 nm: 10 µL(The United States Pharmacopeia 34th; Assay)* Standard solution was prepared from Losartan potassium supplied as a reagent for laboratory use.

min

ロサルタンカリウム
Losartan potassium

D111122A
1CH3N
Cl

System suitability solution *(0.3 mg/mL Losartan potassium, 0.002 mg/mL Triphenylmethanol)

NHOK
N

N

N

1NmAU

Losartan potassium
20215OH

2Triphenylmethanol

105
Tailing factor( Losartan potassium )System suitability
requirement

Result≦1.61.16005Column

1015202530Eluent: YMC-Triart C18 (5 µm, 12 nm)
250 X 4.0 mmI.D.
: A) 0.1% phosphoric acidB) acetonitrile
25-90%B (0-25 min), 90%B (25-35 min)Flow rate
TemperatureDetection: 1.0 mL/min: 25℃: UV at 220 nm

35min

Injection: 10 µL(The United States Pharmacopeia 34th; Chromatographic purity)* System suitability solution was prepared from Losartan potassium supplied as a reagent for laboratory use.

ロサルタンカリウム錠
Losartan potassium tablets

D111229B
1Cl1mAU

CH3N1A) Assay: Standard solution* (0.25 mg/mL Losartan potassium)

N

HOK

800

NNN
N600

Losartan Potassium

400

System suitability
requirement

ResultTheoretical plate number(Losartan potassium)

≧3000

6300

Tailing factor( Losartan potassium )

≦2.0

1.59

2000D111114C
0105min

1B) Impurities: Standard solution* (0.0025 mg/mL Losartan potassium)
mAU

110

System suitability
requirement

ResultTheoretical plate number(Losartan potassium)

≧3000

12200

Tailing factor( Losartan potassium )

≦2.0

1.18

Relative standard deviationof the peak area
(Losartan potassium)

≦5.0%

0.60%

50D111114B
5010minColumn: YMC-Triart C8 (5 µm, 12 nm)
150 X 4.0 mmI.D.

Eluent: A) phosphate buffer (pH 6.7)*2/acetonitrile (85/15)
B) acetonitrile
20-60%B (0-10 min)2

* Dissolve 1.25 g of KH2PO4 and 2.01 g Na2HPO4･12H2O in 1000 mL of water

Flow rate
Temperature: 1.0 mL/min: 25℃Detection: UV at 250 nm
Injection: 10 µL(The United States Pharmacopeia 34th)
1* Standard solution was prepared from Losartan potassium supplied as a reagent for laboratory use.

ロサルタンカリウム錠
Losartan potassium tablets

D111031B1CH3NCl
1Standard solution *(0.05 mg/mL Losartan potassium)

NHOKmAU

1NNN
N

400

Losartan potassium
300

200

System suitability
requirement

ResultTheoretical plate number(Losartan potassium)

≧3000

4700

Relative standard deviationof the peak area
(Losartan potassium)

≦2.0%

0.07%

100

00

24Column: YMC-Pack C8 (10 µm, 12 nm)

Eluent

250 X 4.6 mmI.D.
: phosphate buffer (pH 2.5)*2/acetonitrile (40/60)

6min*2 Dissolve 1.36 g of KH2PO4 in 1000 mL of water, and adjust pH 2.5 with H3PO4

Flow rate: 1.4 mL/min
Temperature: 25℃
Detection: UV at 230 nm
Injection: 20 µL(The United States Pharmacopeia 34th; Uniformity of dosage units)
1* Standard solution was prepared from Losartan potassium supplied as a reagent for laboratory use.