Module 3 - Strategic case studies in practice

COLD RELIEF CAPSULES/GRANULES

METHOD OF TEST

PHENYLEPHRINE HYDROCHLORIDE, CAFFEINE, PARACETAMOL

EQUIPMENT:

Suitable HPLC system with UV detection and a computing integrator.

STANDARDS:

Internal Standard Solution:

0.100% w/v 2-Naphthol in Methanol.

2.

Ion Pairing Solution

Dissolve 0.275 g Octane Sulphonic acid (Sodium Salt) in water, add 2.5 mls acetic acid, add 30 mls methanol and dilute to 100 mls with water. Weigh accurately approximately 50 mg Phenylephrine Hydrochloride and 250 mg Caffeine into a 100 ml volumetric flask. Make up to the mark with methanol and mix well - solution A. Into a 50 ml volumetric flask weigh accurately 300 mg paracetamol and dissolve ~n 30 ml methanol. Pipette in 10 ml solution A, make up to the mark with methanol and mix well - solution B.

3.

Stock Standard:

Working Paracetamol Standard:

Into a screw capped bottle pipette 2 ml solution B and 5 ml Internal Standard. Add approximately 2S ml methanol and mix well.

5.

Working Phenylephrine/ Caffeine Standard~

Into a screw capped bottle pipette 10 ml solution B and 5 ml Internal Standard. Mix well. Add 10 ml of Ion Pairing solution. Mix well.