Temperature control in HPLC proves formulation of APIs

Published: 7-Jan-2005
Regulatory


Temperature Programmed Liquid Chromatography (TPLC) specialist Selerity Technologies, of Utah in the US, has shown that its Polaratherm Total Temperature Controller and oven offer a proven method for the separation of APIs.

Under experimental conditions, Selerity used temperature as the key parameter to successfully analyse two sources of sildenafil citrate, the active ingredient in Viagra, to determine actual levels of the ingredient and compare them with the stated formulation.

Since the launch of Viagra by Pfizer in 1998, several copycats have been produced by companies based in Belize and marketed over the internet. Selerity compared a genuine Viagra tablet with one of the offshore alternatives: both tablets claimed to contain 100mg of sildenafil citrate.

Both extracts were analysed by High Temperature Liquid Chromatography (HTLC) using a thermal gradient. The results unequivocally indicated that the sildenafil citrate tablet purchased via the internet was significantly inferior, containing 20% less of the active ingredient than the original Viagra tablet. Additionally, the analysis of the Viagra sample confirmed that it does contain the stated amount of active ingredient. No degradation occurred when performing the analysis at elevated temperatures.

Selerity has recorded the results of this experiment in a new application note (number 807) available at www.selerity.com/main/main_literature_appnotes.html

sales@selerity.com www.selerity.com

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