Estimation of Enantiomeric Impurity in Piperidin‐3‐Amine by Chiral HPLC With Precolumn Derivatization |
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| Authors: | Chittabathina Venkata Raghunadha Babu Nagi Reddy Vuyyuru K Padmaja Reddy MV Suryanarayana K Mukkanti |
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| Affiliation: | 1. Dr. Reddy's Laboratories Ltd. IPDO, Hyderabad, A.P, India;2. Center for Pharmaceutical Sciences, IST, J.N.T.University, Hyderabad, A.P, India |
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| Abstract: | A simple, precise, accurate, robust chiral high‐performance liquid chromatographic (chiral HPLC) method was developed for estimation of (S)‐piperidin‐3‐amine (S‐isomer) in (R)‐piperidin‐3‐amine dihydrochloride (R‐AMP). As AMP is a high‐melting solid and nonchromophoric compound, development of a suitable chiral method is a challenging task. The proposed chiral HPLC‐UV method involves a precolumn derivatization technique with para toluene sulphonyl chloride (PTSC) in the presence of a base to introduce chromophore into analytes. It utilizes chiralpak AD‐H column with a simple mobile phase of 0.1% diethyl amine in ethanol with a 0.5 mL/min flow rate. Analytes were monitored by using a UV detector at 228 nm. The resolution between the two enantiomers was more than 4.0. The developed method was validated as per current International Conference on Harmonization (ICH) guidelines. Chirality 26:775–779, 2014. © 2014 Wiley Periodicals, Inc. |
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| Keywords: | enantiomers PTSC polar mode ICH validation |
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