Analysis method of Montelukast sodium and levocetirizine Dihydrochloride Syrup
1.1 To lay down a procedure for analysis of Montelukast sodium & levocetirizine Hydrochloride Syrup
2.1 This procedure is applicable to the analysis of Montelukast sodium and levocetirizine Hydrochloride Syrup QC lab
3.1 Q.C- Chemist
4.1 Managers-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 Hydrochloride I.P. 2.5 mg.
Montelukast sodium Eq. to
Estimation of Montelukast sodium & Levocetirizine Hydrochloride
Method of Montelukast sodium & Levocetirizine Hydrochloride:
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 and 80 mg of Montelukast sodium. diluted to 100 ml volumetric flask with mobile phase. Further dilution 5.0 to 50 ml with mobile phase
Test preparation: Weight accurately10 ml spl. wt. diluted to 100 ml volumetric flask with mobile phase.
Flow rate- 1.2ml –mint.
Injection volume 50 micro lit.
Column: C18 (125mm x4.6) 5.0 micron.
Retention time: Levocetirizine hcl- 1.8 mint.
Montelukast sodium-8.0 mint.
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|1.0||STP||Standard Testing Procedure|
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