Analysis method of Ambroxol Hydrochloride Drops
1.1 To lay down a procedure for analysis of Ambroxol Hydrochloride Drops.
2.1 This procedure is applicable to the analysis of Ambroxol Hydrochloride Drops. in Quality Control lab
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 5ml contains.
Ambroxol Hydrochloride I.P. 15 mg.
Estimation of Ambroxol Hydrochloride drops.
Method of Ambroxol Hydrochloride:
BUFFER: 2.7 gm of potassium dihydrogen orthophosphate. diluted 1000 ml water. Adjust to pH. 4.0 with orthophoshoric acid.
Mobile phase: BUFFER: ACETONITRILE
70 : 30
Standard preparation: Weight accurately about 30mg Standard wt. of Ambroxol hydrochloride. diluted to 100 ml volumetric flask with mobile phase.
Sample preparation: Weight accurately Equivalent to 30mg sample wt. of Ambroxol hydrochloride. diluted to 100ml
volumetric flask with mobile phase.
Wavelength -215 nm
Flow rate – 1.0 ml/mint.
Column – C18 (250mm x4.6) 5µm
Injection volume -20 µl.
Temperature – Ambient temp.
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|1.0||STP||Standard Testing Procedure|
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