Sun Pharmaceutical Industries Limited

Raja Sekhar Unnam

Rajamannar Thennati

Trinadha Rao Chitturi

Kanaksinh Jesingbhai Jadav

Shivramchandra Kanangi

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&#xb1;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 Ccolumn (15 cm&#xd7;4.6 mm, 5 &#x3bc;m particle size) with the following parameters:  The present invention also provides a process for the preparation of substantially pure desloratadine by the process comprising acidic hydrolysis of a compound of formula 3 where R is selected from COR, COORwherein Ris selected from branched or linear alkyl (1-6 C), cycloalkyl, alkenyl, alkynyl, aryl, aralkyl and their substituted analogs; and their substituted analogs with a strong organic acid or a mineral acid. 

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Baroda, India

Raja Sekhar Unnam