HPLC Method of Cetrizine Hydrochloride IP 5mg and Phenylephrine IP 5 mg

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

HPLC Method