Impurity profile study of loratadine |
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| Authors: | Reddy K V S R Krishna Babu J Moses Kumar Y Ravindra Reddy S Vishnu Vardhan Kumar M Kishore Eswaraiah S Reddy K Rama Subba Reddy M Sayanarayana Bhaskar B Vijaya Dubey P K Vyas K |
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| Affiliation: | Department of Analytical Research, Discovery Research Division, Dr Reddy's Laboratories Ltd., Bollaram Road, Miyapur, Hyderabad 500 050, India. |
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| Abstract: | Three unknown impurities in loratadine bulk drug at levels below 0.1% (ranging from 0.05 to 0.1%) were detected by a simple isocratic reversed-phase high performance liquid chromatography (HPLC). These impurities were isolated from mother liquor sample of loratadine using reversed-phase preparative HPLC. Based on the spectral data (IR, NMR and MS) the structures of these impurities were characterized as 11-(N-carboethoxy-4-piperidylidene)-6,11-dihydro-5H-benzo(5,6) cyclopenta(1,2-b)-pyridine (I), 8-bromo-11-(N-carboethoxy-4-piperidylidene)-6,11-dihydro-5H-benzo(5,6) cyclopenta (1,2-b)-pyridine (II) and 8-chloro-11-(N-carboethoxy-4-piperidylidene)-5H-benzo(5,6) cyclopenta (1,2-b)-pyridine (III). The synthesis of these impurities was discussed. |
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