Module 3 - Strategic case studies in practice

COLD RELIEF CAPSULES/GRANULES

METHOD OF TEST

PROCEDURE

Set up the HPLC system as follows:-

Sui table ODS 30:60:1 methanol, deionised water, acetic acid containing 1.1 g octane Sulphonic acid (sodium salt) per litre. (If necessary adjust proportions to suit particular ODS 1n use).

Column: Eluant:

0

Wavelength: 280 nm Range: 0.2 Aufs Injection: 10 pl Rheodyne. Allow the system to equilibrate.

SAMPLE PREPARATION

Transfer the powder from 10 capsules quantitatively into a 500 ml volumetric flask, washing out the empty capsules shells with a small portion of Methanol, dilute to volume with methanol. Stir for 15 minutes. Allow to settle (Solution C). Pipette 2 ml solution C and 5 ml Internal Standard to a screw capped bottle, add 25 ml methanol, mix well. Pipette 10 ml solution C and 5 ml Internal Standard to a screw capped bottle, mix well. Immediately prior to injection add 10 ml Ion Pairing solution, mix well. Inject the working Paracetamol Standard into the HPLC system and identify the resulting peaks corresponding to paracetamol and the internal standard. Calibrate the integrator for Internal Standard setting the paracetamol peak amount to the weight (mg) taken. Re– inject the standard to ensure reproducibility.

Paracetamol

Phenylephrine/Caffeine:

(J

HPLC PROCEDURE

Paracetamol