Analysis method of Levocetirizine Dihydrochloride syrup
1.1 To lay down a procedure for analysis of Levocetirizine Dihydrochloride Syrup.
2.1 This procedure is applicable to the analysis of Levocetirizine Dihydrochloride Syrup quality control laboratory
3.1 Q.C- Chemist
4.1 Manager-Quality Assurance
5.1 Description: Pour 50ml finish sample in beaker and observed visually.
5.2 pH: Taken 50 ml sample in beaker rinse the pH electrode first with purified water followed by sample dip the electrode in sample and observed the pH.
5.3 Volume variation: Measured the volume by measuring cylinder and determine the volume variation.
5.4.1 In the assay, the principle peak in the chromatogram obtain with the test solution correspond to the peak in the chromatogram obtained with the reference solution.
Each 5.0 ml contains:
Levocetirizine Dihydrochloride I.P. 2.5 mg.
Estimation Levocetirizine Dihydrochloride:
Method of Levocetirizine Dihydrochloride:
BUFFER: Dissolve 3.85 Ammonium Acetate 1000 ml of distilled water adjust to ph. 5.5 with Glacial Acetic acid.
MOBILE PHASE: BUFFER : METHANOL
20 : 80
Standard preparation: Weight accurately about 50mg std wt. of Levocetirizine Dihydrochloride diluted to 100 ml volumetric flask with mobile phase. Further dilution 5.0 to 50 ml with mobile phase
Sample preparation: Taken 10ml sample diluted to 100 ml volumetric flask with mobile phase.
Wavelength – 220nm.
Flow rate – 1.2 ml/mint.
Injection volume -50 µl.
Column – C18 125mm x4.6 (5.0 µm.)
Temperature – 250c
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|1.0||STP||Standard Testing Procedure|
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