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Used to treat high blood pressure. It is also used to lower the risk of
strokes in patients with high blood pressure and an enlarged heart.
Lowering high blood pressure helps prevent strokes, heart attacks, and
kidney problems.

Each Tablet Contains:

Losartan Potassium . . . . 50mg

Amlodipine Besilate . . . . 5mg

Hydrochlorothiazide . . . .12.5mg

Chromatographic Conditions:

Column : 250 × 4.6 mm, 5µm C18

Detector : 238 nm

Injection volume : 20µl

Flow rate : 1 ml/ minute

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Column temperature : Ambient

Mobile phase : Phosphate buffer (pH 7.0), Methanol : Acetonitrile

(60:20:20% v/v)

Preparation of Phosphate Buffer (pH 7):

Dissolve 6.8 gm of KH2PO4 in 1000ml of water and adjust pH 7 with

Potassium Hydroxide then mix the buffer.

Preparation of Standard Solution:

Weigh accurately 250mg Losartan potassium, 34.8mg of Amlodipine

besilate and 62.5 mg of hydrochlorothiazide, transferred in 100 mL
volumetric flask, dissolve in 15ml of mobile phase, sonicated for 15 min and
make up the volume with mobile phase.

Transfer 5ml of Standard Solution in 50ml volumetric flask and further

dilute with mobile phase.

Preparation of Sample Preparation:

Weigh and Powder 20 tablets. Weigh tablet powder equivalent to 250mg

Losartan potassium, 34.8mg of Amlodipine besilate and 62.5mg of
hydrochlorothiazide, transferred in 100 mL volumetric flask, dissolve in
30ml of mobile phase, sonicated for 30 min and make up the volume with
mobile phase. Filter with 0.45 micron filter.

Transfer 5ml of clear solution in 50ml volumetric flask and further dilute
with mobile phase.

System Suitability

The % RSD for 5 replicate injection of standard preparation should NMT 2.0
%.

Procedure:

Inject standard preparation in five replicate and record the chromatogram.

It should comply with the system suitability criteria as mention above. Inject
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sample preparation in duplicate, record the chromatogram and calculate

the percent of assay by using the following formula:

Calculation:

Where,

At = Average area of Sample solution

As = Average area of Standard solution

Ws = Weight of Standard

Wt = Weight of Sample

ATW = Average Tablet Weight

L = Label Claim

P = Potency of Standard

NOTE: Analyst have to perform Method Validation as per Regulatory

Guidelines.

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