Abstract

QUALITY ASSESSMENT STUDIES OF FIVE DIFFERENT BRANDS OF SILDENAFIL CITRATE MARKETED IN NIGERIA

Ezealisiji K. M.* and Chukwunweike C. Chioma

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Abstract

Quality is phenomenon that characterizes a thing and every pharmaceutical company strives for it but often a time it is very difficult to achieve. The quality of a pharmaceutical product is very important to achieve by following certain parameters that are specified in respective monograph. This research work aim to investigate the quality of five different brands of Sildenafil Citrate (Viagra®, Upgra, Manup, Man-G, Vega) marketed in Nigeria which in turn would help determine whether they meet the British or United States Pharmacopeia (BP /USP) requirement. The brands of these drugs were all purchased in Nigeria. The various brands were subjected to physical parameter tests such as weight uniformity, hardness, friability, disintegration, dissolution, and percentage content of active ingredient tests. All the brands except Upgra met the BP specification for weight uniformity. From the experiment on friability and disintegration it was seen that all the brands met the official requirement. In the test for hardness all the tablets from the innovator brand passed the test, only 8 tablets passed for Man-G, all the tablets from the remaining brand did not meet the specification. From the dissolution result it was seen that all brand failed as they did not meet the requirement of releasing at least 80% of its active substance at 30minutes. From the experiment on percentage content of active ingredient only three brands (Man-G, Vega, Upgra) fell within USP specifications, the innovator and Manup were outside USP specification (114.9 % and 113.9 % respectively).

Keywords: Sildenafil, Disintegration, Friability, Weight uniformity, Dissolution.