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Sci. Pharm. 2015, 83(3), 453-463; doi:10.3797/scipharm.1501-16

Cost-Effective Isolation of a Process Impurity of Pregabalin

1
Department of Analytical Research and Development, Dr. Reddy's, Laboratories Ltd, IPDO, Hyderabad, 500072, Telangana, India
2
Pharmaceutical Chemistry Division, School of Advanced Sciences, VIT University Vellore-632014, TN, India
*
Author to whom correspondence should be addressed.
Received: 30 January 2015 / Accepted: 25 March 2015 / Published: 25 March 2015
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Abstract

Cost-effective isolation methods were developed on preparative HPLC, flash LC, and simulated moving bed (SMB) to prepare the process impurity, 3-(aminomethyl)-5-methylhex-4-enoic acid (4-ene impurity), of pregabalin. By a thorough experimental study on the different isolation techniques available, it was concluded that SMB was the most cost-effective. Hence, it was a continuous chromatography that utilized the advantage of SMB so that a high quantity of the impurity was generated in a short period of time. SMB was equipped with eight reversed-phased columns and was used to separate the process impurity of pregabalin. The effects of flow rate in zone 2 (Q2) and 3 (Q3), as well as switching time, on the operating performance parameters like purity, productivity, and desorbent consumption were studied. Operating conditions leading to more than 90% purity in the raffinate outlet stream were identified, together with those achieving optimal performance. All of these developed methods are novel, cost-effective, and can be applied to the isolation of other process- and stability-related impurities of pregabalin.
Keywords: Pregabalin; Impurity; Isolation; Preparative HPLC; Flash chromatography; Simulating moving bed Pregabalin; Impurity; Isolation; Preparative HPLC; Flash chromatography; Simulating moving bed
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

PRAKASH, L.; HIMAJA, M.; RAMAKRISHNA YADAV, B.; MAHESHWARA REDDY, A. Cost-Effective Isolation of a Process Impurity of Pregabalin. Sci. Pharm. 2015, 83, 453-463.

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