Module 3 - Strategic case studies in practice

COLD RELIEF CAPSULES/GRANULES

METHOD OF TEST

Phenylephrine/Caffeine

Inject the working Phenylephrine/Caffeine Standard and identify the peaks corresponding to Phenylephrine, Caffeine and Internal Standard. Calibrate the integrator for Internal Standard setting the peak amount to the weight (mg) taken/10. Re-inject the standard to ensure reproducibility.

Results:

The integrator printout will express the results for each component as mg/capsule.

Uniformity of Content Phenylephrine Hydrochloride

Take a sample of 10 capsules from throughout the batch. Open each individual capsu-le and transfer the contents via a small funnel into a 50 ml volumetric flask. Wash out the shells and funnel with about 30 ml of methanol. Make up to the mark with methanol and stir for 15 minutes. Allow to settle. Pipette 10 ml of each solution and 5 ml of Internal Standard into a series of screw capped bottles. Mix well. Immediately pr1or to injection add 10 mls of Ion Pairing solution, mix well. Proceed as for the analysis of the sample using the Phenylephrine/Caffeine procedure but only calibrating for Phenylephrine Hydrochloride. The multiplier is 1.00 for all samples. The results will be printed as mg/capsule.

CJ