Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurities in Verapamil Hydrochloride

Viswanathan SRINIVASAN; Hariharan SIVARAMAKRISHNAN; Balakrishnan KARTHIKEYAN

doi:10.3797/scipharm.1101-19

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Article

8 May 2011

Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurities in Verapamil Hydrochloride

and

Analytical Development Laboratory, Piramal Healthcare Ltd, Ennore, Chennai 600 057, India

Department of Chemistry, Annamalai University, Annamalainagar 608 002, India

Research and Development Laboratory, Piramal Healthcare Ltd, Ennore, Chennai 600 057, India

Author to whom correspondence should be addressed.

Sci. Pharm.2011, 79(3), 555-568;https://doi.org/10.3797/scipharm.1101-19

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Abstract

Two unknown impurities were detected in verapamil hydrochloride bulk drug using isocratic reversed-phase high performance liquid chromatography (HPLC). These impurities were isolated by preparative HPLC. Spectral data for the isolated impurities were collected. Based on the spectral data derived from two-dimensional nuclear magnetic resonance (2D-NMR) spectroscopy and mass spectrometry (MS), impurity-1 and impurity-2 were characterized as 2-(3,4-dimethoxyphenyl)-3-methylbut-2-enenitrile and 2-(3,4-dimethoxyphenyl)-2-isopropyl-3-methylbutanenitrile, respectively.

Keywords:

Verapamil hydrochloride; NMR; HPLC; MS; Impurity Analysis

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