Quality of Sulfadoxine-pyrimethamine (SP) tablets sold in drug outlets in Arua District, Uganda

Abstract

Background: Sulfadoxine-pyrimethamine (SP) remain a corner stone in intermittent preventive treatment (IPT) of malaria in pregnancy. Reports of substandard and counterfeit antimalarial drugs in Uganda and neighbouring countries like DRC and Sudan continue to raise fears over the quality of SP in drug outlets in Arua District which neighbours and trades with the above countries. This study was designed to assess the post market quality of SP tablets in drug shops and clinics in Arua Municipality, Arua District.

Methods: The study involved sampling various batches of SP tablets from Arua Hill and Oli divisions in Arua municipality. The laboratory analysis involved: physical/ visual inspection, weight uniformity test, physicochemical assay for dissolution and quantitative content analysis performed according to USP and BP (2009) methods.

Results: A total of 19 SP batches were purchased from 8 drug shops and 11 clinics in the municipality. Majority (73.7%) of the samples were obtained from Arua Hill Division while 26.3% of the samples were procured from Oli Division. The SP tablets originated from various countries; Uganda (40%), India (30%), Kenya (20%) and Cyprus (10%). The country of origin of one sample could not be determined because it was sold in a plastic tin for Albendazole. Fifty percent (50%) of the brands were non existent in the December 2008 and September 2009 human drug register in NDA. One out of the ten batches failed dissolution test due to low amount of pyrimethamine (56.1±3.1). However, all the ten batches passed the USP and BP tolerance limits for content.

Conclusion: The current study indicates low level of substandard SP tablets in Arua Municipality thus the need for sustained antimalarial drug quality surveillance programme in the country by National Drug Authority.