Analysis of Levocetirizine Tablets
TESTS 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. Uniformity of Content: Use the chromatographic condition of assay to perform the Uniformity of content.
Standard Preparation
As described in the assay
Test Preparation
1 tablet in 100 ml of Volumetric Flask dissolve in 50 ml of mobile phase heat upto 45°C, sonicate for 1 minute and dilute to 100 ml with mobile phase.
Procedure
As described in the assay
Calculation
05 Dissolution Apparatus No. 1, Paddle
Medium. 900 ml of phosphate buffer pH 6.8,
(40.8 gm KH2PO4 + 5.4 gm Sodium hydroxide dissolve in 6.0 liters water).
Speed and time- 50 rpm for 30 minutes.
Withdraw a suitable volume of the medium and filter. Determine by HPLC Spectrophotometer
Standard Preparation: Weight Accurately about 50 mg WS of levocetirizine dihydrochloride in 100 ml of Volumetric Flask dissolve in 50 ml of mobile phase heat upto 45°C, sonicate for 1 minute and dilute to 100 ml with mobile phase.
To 2 ml dilute to 200 ml with dissolution medium.
(Keep at 37°C at least for 30 minutes)
D. Not less than 75%.
Procedure
As described in the assay
Assay Buffer – 680 mg Potassium dihydrogen phosphate dilute to 100 ml with water
Mobile phase-60V Buffer+40V Acetonitrile adjust pH-6.0 with 1N Sodium hydroxide.
Sodium Hydroxide- 40 gm Sodium hydroxide dissolve in 1000 ml water.
Column- A stainless steel column 250 x 4.6 mm to porous silica
Flow rate : 1 ml per minute
Wavelength : 230 nm
Injection volume: 20 µL
Standard Preparation: Weight Accurately about 50 mg WS of levocetirizine dihydrochloride in 100 ml of Volumetric Flask dissolve in 50 ml of mobile phase heat upto 45°C, sonicate for 1 minute and dilute to 100 ml with mobile phase.
To 5 ml dilute to 50 ml with mobile phase.
Test Preparation: weight & powder 20 Tablets weight Accurately Eq. to 25 mg of levocetirizine dihydrochloride in 100 ml of Volumetric Flask dissolve in 50 ml of mobile phase heat upto 45°C, sonicate for 1 minute and dilute to 100 ml with mobile phase.
To 5 ml dilute to 25 ml with mobile phase.
Calculation
Abbreviations:
WS- working standard
VF-Volumetric flask
STD-Standard
Spl.-Sample
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Analysis of Levocetirizine Tablets
