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Article

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.
Sci. Pharm. 2014, 82(1), 117-128; https://doi.org/10.3797/scipharm.1309-12
Submission received: 22 September 2013 / Accepted: 14 November 2013 / Published: 14 November 2013

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

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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. https://doi.org/10.3797/scipharm.1309-12

AMA Style

KADIYALA RVSN, KOTHAPALLI PKSR, PEDDOLLA MR, RAJPUT P, SHARMA HK, BUDETI SR, 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. Scientia Pharmaceutica. 2014; 82(1):117-128. https://doi.org/10.3797/scipharm.1309-12

Chicago/Turabian Style

KADIYALA, Raju V. S. N., Pavan Kumar S. R. KOTHAPALLI, Madhava Reddy PEDDOLLA, Pradeep RAJPUT, Hemant Kumar SHARMA, Shankar Reddy BUDETI, Himabindu GANDHAM, and Annapurna NOWDURI. 2014. "Development and Validation of a Gas Chromatography Method for the Trace Level Determination of Allylamine in Sevelamer Hydrochloride and Sevelamer Carbonate Drug Substances" Scientia Pharmaceutica 82, no. 1: 117-128. https://doi.org/10.3797/scipharm.1309-12

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