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Sci. Pharm. 2014, 82(1), 117-128; doi:10.3797/scipharm.1309-12

Development and Validation of a Gas Chromatography Method for the Trace Level Determination of Allylamine in Sevelamer Hydrochloride and Sevelamer Carbonate Drug Substances

1
Aurobindo Pharma Ltd Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Andhra Pradesh, India
2
Andhra University College of Engineering, Visakhapatnam-530003, Andhra Pradesh, India
*
Authors to whom correspondence should be addressed.
Received: 22 September 2013 / Accepted: 14 November 2013 / Published: 14 November 2013
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Abstract

A capillary gas chromatography method using a flame ionization detector has been developed for the trace analysis of allylamine (AA) in sevelamer hydrochloride (SVH) and sevelamer carbonate (SVC) drug substances. The method utilized a mega bore capillary column DB-CAM (30 m x 0.53 mm x 1.0 μm) with a bonded and cross-linked, base-deactivated polyethylene glycol stationary phase and was validated for specificity, sensitivity, precision, linearity, and accuracy. The detection and quantitation limits obtained for allylamine were 2 μg/g and 6 μg/g, respectively. The method was found to be linear in the range between 6 μg/g and 148 μg/g with a correlation coefficient of 0.9990. The average recoveries obtained in SVH and SVC were 93.9% and 99.1%, respectively. The developed method was found to be robust for the determination of AA in sevelamer drug substances and also the specificity was demonstrated with a gas chromatograph coupled with a mass spectrometer.
Keywords: Allylamine; Sevelamer hydrochloride; Sevelamer carbonate; Gas chromatography with Flame ionization detector Allylamine; Sevelamer hydrochloride; Sevelamer carbonate; Gas chromatography with Flame ionization detector
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

KADIYALA, R.V.S.N.; KOTHAPALLI, P.K.S.R.; PEDDOLLA, M.R.; RAJPUT, P.; SHARMA, H.K.; BUDETI, S.R.; GANDHAM, H.; NOWDURI, A. Development and Validation of a Gas Chromatography Method for the Trace Level Determination of Allylamine in Sevelamer Hydrochloride and Sevelamer Carbonate Drug Substances. Sci. Pharm. 2014, 82, 117-128.

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