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HPLC Methods for Simultaneous Estimation of Amlodipine Besilate, Losartan Potassium and Hydrochlorothiazide in Tablets

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
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 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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