Determination of Tandospirone and its Impurities in Drug Formulations by LC-UV and LC-MS |
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Authors: | Meiling Qi Peng Wang Gaokeng Xiao |
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Affiliation: | (1) Department of Chemistry, School of Chemical Engineering and Materials Science, Beijing Institute of Technology, Beijing 100081, China;(2) Shenyang Pharmtech Institute of Pharmaceuticals, Shenyang, 110015, China |
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Abstract: | This work describes the determination of tandospirone in bulk drug substance and formulated products by a reversed-phase liquid chromatographic method with UV detection. Chromatographic separation was performed on a C18 column with a mobile phase of a binary mixture of methanol and water (70:30, v/v) delivered at a flow rate of 0.5 mL min–1 and detection was performed at 243 nm. The proposed LC method is selective, precise and accurate for the determination of tandospirone in the presence of its manufacturing impurities with a limit of quantitation of 0.54 g mL–1. A preliminary study for the identification of the major manufacturing impurities was made by liquid chromatography-mass spectrometry with electrospray ionization source operated in a positive ion mode. |
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Keywords: | Column liquid chromatography Mass spectrometry detection Tandospirone Impurities in bulk drug |
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