Analysis method of Paracetamol Phenylephrine hydrochloride and Chlorpheniramine Maleate in oral liquid
1.1 To lay down a procedure for analysis of Paracetamol, Phenylephrine hydrochloride and Chlorpheniramine Maleate.
2.1 This procedure is applicable to the analysis of Paracetamol, Phenylephrine hydrochloride and Chlorpheniramine Maleate
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 1.0 ml contains:
Paracetamol I.P. 125 mg.
Phenylephrine hydrochloride I.P. 5 mg.
Chlorpheniramine Maleate I.P. 0.5 mg.
Estimation of Paracetamol Phenylephrine hydrochloride and Chlorpheniramine Maleate:
Method of Paracetamol, Phenylephrine hydrochloride and Chlorpheniramine Maleate:
Buffer: 2.72 gm Potassium Dihydrogen Orthophosphate add 3.0 ml Triethylamine 1000 ml water. Adjust to pH 2.5 with Orthophoshoric acid.
Mobile phase: Acetonitrile: Methanol: Buffer
15 : 15 : 70
Diluent: Acetonitrile: Buffer
10 : 90
Standard preparation: Weight accurately about 250 mg standard weight of Paracetamol diluted to 100 ml volumetric flask with diluent. 100 mg of Phenylephrine hydrochloride and 50 mg of Chlorpheniramine Maleate diluted to 100 ml with diluent. Further dilution 10 ml of Phenylephrine and Chlorpheniramine Maleate diluted to 100 ml volumetric flask with diluent.
Test preparation: Taking accurately equivalent weight test sample to be taken standard dilution.
Wavelength – 280 nm
Flow rate – 1.0 ml/mint
Injection – 20 micro ltr.
Column C18 125mm x 4.6 (5 micron)
Retention time of phenylephrine- 1.48 mint.
Retention time of paracetamol- 2.04 mint.
Retention time of chlorpheniramine maleate-6.48 mint.
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|1.0||STP||Standard Testing Procedure|
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