Patent 7678908 was granted and assigned to Sun Pharmaceutical on March, 2010 by the United States Patent and Trademark Office.
The present invention provides substantially pure desloratadine having an HPLC purity greater than 99.5% and having an absorbance less than 0.15 Au at 420 nm for a 5% w/v solution in methanol, which does not show a peak for an impurity at a relative retention time in the range from about 0.85 to about 0.99 (relative to desloratadine appearing at a retention time of 25±5 minutes), which is greater than the discard limit set at less than 0.025% of the total area, when tested according to an HPLC method performed using a Hypersil BDS C8 column (15 cm×4.6 mm, 5 μm particle size) with the following parameters: