Development and validation of a reversed-phase HPLC method for determination of lesatropane and enantiomeric impurity |
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Authors: | Yang Li-Min Xie Yi-Fan Gu Zhou-Hui Wang Ai-Ling Chen Hong-Zhuan Lu Yang |
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Institution: | Department of Pharmacy, Shanghai Jiao Tong University School of Medicine, Shanghai, China. |
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Abstract: | Lesatropane is a novel muscarinic receptor agonist and is currently being under preclinical development in China as a single enantiomer drug for the treatment of primary glaucoma. A reversed-phase chiral HPLC method for determination of lesatropane and enantiomeric impurity was developed. Enantiomeric separation of lesatropane from its enantiomer (desatropane) was achieved in normal-phase mode with Chiralpak AD-H and in reversed-phase mode with Chiralpak AS-RH. The conditions using a Chiralpak AS-RH column and mobile phase of K(2) HPO(4) -KH(2) PO(4) (pH 7.0; 0.02 M)-acetonitrile (69:31, v/v) at a flow rate of 0.5 ml/min have been fully validated with satisfactory specificity, linearity, accuracy, and precision. The method was found to be suitable for the simultaneous quantitation of lesatropane and enantiomeric impurity desatropane. |
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Keywords: | enantiomeric separation lesatropane amylose‐based chiral stationary phase muscarinic agonist |
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