Tue, 21 Nov 2017

Assessment of in-Home and in-Use Stability of Paracetamol Pediatric Oral Suspension through Simulate room temperature Storage Conditions

Layla Fathi1*, Dhia E. Elhag1

1. Faculty of Pharmacy, University of Medical Sciences and Technology, Khartoum, Sudan.


ABSTRACT

This study examines the stability of paracetamol pediatric oral suspension (120mg/5ml) in simulated in-home storage conditions, temperature ranging from (300±5C/65±5RH) representing room condition. Samples from suspension were assayed for active pharmaceutical ingredient and tested for related substance (degradants) using B.P 2012 pharmacopeia HPLC method. The study was carried out in day zero, seven, fourteen, thirty and forty five.  The instrument utilize column ® C8, 100 x 4.6 mm, 3.5 μm particle size. The flow rate was 1.5 ml/minute. The mobile phase consisted of methanol, tetrabutylammonium hydroxide and sodium orthophosphate buffer. The results obtained showed that the drug assay content was out of the limits from day zero Furthermore, the half live was found to be 35.06 days

Keyword: Paracetamol, 4-amino phenol, degradation, HPLC.


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