Description: Off white/Yellow/Orange coloured granular powder.
Observation:………………………………………………………. (Complies/Not Complies)
Average weight:
Identification:
- Phenylephrine:In the assay, the principal peak in the chromatogram obtained with the test solution corresponds to that in chromatogram obtained with the reference solution.
(Complies/Not complies)
- Cetrizine Hydrochloride:In the assay, the principal peak in the chromatogram obtained with the test solution corresponds to that in chromatogram obtained with the reference solution. (Complies/Not complies)
Assay: Each uncoated tablet contains:
Cetirizine Hydrochloride IP 5mg and Phenylephrine IP 5 mg
Procedure:
Working standard dilution: 25 mg Cetrizine+25mg Phenylepherine à50 ml M.P.à 5 ml à 50 ml M.P.
Test dilution:Avg.wt.à100ml M.P. (Sonicate for 10 min and filter)
Mobile Phase: [600 ml water+400 ml Acetonitrile+1 ml trithylamine pH-3.5 with orthophosphoric Acid]
Column : C18(150×4.6 mm)
Flow Rate: 1.2 ml/min
Formula:
Area of Test STD Wt.(mg) 5 100 Potency
——————X—————-X——–X—————X———XAvg.wt.
Area of STD 50 50 Test Wt.(mg) 100
