Analysis of Losartan Tablets

TEST PROCEDURE / METHODS

01. Description: Remove 20 tablets from the strip. Place on a white paper and observe visually.

02. Identification

In the assay, the principle peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with reference solution.

03. Average Weight: Weigh accurately 20 tablets and calculate the average weight.
Average Weight = Weight of 20 tablets/20

04 Dissolution Apparatus. No 1, (Paddle)
Medium. 900 ml of water
Speed 50 rpm, and Time-45 minutes.

Withdraw a suitable volume of the medium and filter.
To 10 ml of filtrate and dilute to 25 ml with water.

Standard Preparation
Weigh accurately (about 55 mg) dissolve in 50 ml Water heat upto 40 C, sonicate for 1 minute and dilute to 100 ml with Water,
To 5ml dilute to 100 ml with water and filter.
To 10 ml dilute to 25 ml with water.

Calculation

D. Not less than 75%

Procedure – Measure the absorbance at 250 nm with UV & Visible
Spectrophotometer.

5.0
Related Substances Determine by liquid chromatography

Buffer – Weight (about 770 mg) ammonium acetate dissolve in 900 ml water + 2 ml Triethylamine adjust pH- 6.5 with glacial acetic acid and dilute to 1000 ml with water.

Mobile phase. A mixture of 75V buffer and 25V Acetonitrile.

Column – 250 x 4.0 mm, 5µm (C8)
Flow Rate -1.5 ml per minute
Wavelength – 235 nm
Injection volume- 10 µL
Run Time – 40 minutes

Sequence of Injection

S.No.	Particular	No. of Injection
1	Check RT	1
2	Standard	5
3	Test	2
4	Column conditioning	1
5	RS Placebo	1
6	Reference Solution B (RS)	1
7	Test Solution (RS)	1

Test Preparation
Weigh and powder of 20 tablets take powder eq. to 100 mg of Losartan Potassium (about 680 mg) dissolve in 50 ml water and dilute to 100 ml with water.

Reference solution A
Weigh accurately (about 50 mg) Losartan potassium WS dissolve in 40 ml water and dilute to 50 ml with water.

Reference Solution B
To 1 ml of Ref Solution A dilute to 100 ml water.

Column Efficiency

Tailing Factor – Limit NMT NMT 3.0
Theoretical Plates – Limit NLT 1000

Calculation

6.0 Assay By High Performance Liquid Chromatography

Buffer- 770 mg ammonium acetate dissolve in 1000 ml water

Mobile phase- 650 Buffer +300 Acetonitrile +50 ml methanol+2 ml Triethylamine and adjust pH- 6.6 with Glacial acetic acid.

Column – 250 x 4.0 mm, 5µm (C8)
Flow Rate -1.0 ml per minute
Wavelength – 237 nm
Injection volume- 20 µL

Standard Preparation
Weigh accurately (about 65 mg) Losartan Potassium WS dissolve in 20 ml mobile phase heat upto 40°C, sonicate for 1 minute and dilute to 50 ml with mobile phase.
To 5ml dilute to 50 ml with mobile phase.

Test Preparation
Weigh and powder of 20 tablets take powder about (442 mg) mg dissolve in 20 ml mobile phase heat upto 40 C, sonicate for 1 minute and dilute to 50 ml with mobile phase.
To 5ml dilute to 50 ml with mobile phase.

Column Efficiency

Tailing Factor …………….. Limit NMT 2.0

Theoretical Plate ……………… Limit NLT 5000

Calculation