title: Development and validation of a gas chromatography method for the trace level determination of allylamine in sevelamer hydrochloride and sevelamer carbonate drug substances.
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 × 0.53 mm × 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.
authors.affiliation: Aurobindo Pharma Ltd Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Andhra Pradesh, India.
authors.forename: Raju V S N
authors.initials: RV
authors.lastname: Kadiyala
authors.affiliation: Aurobindo Pharma Ltd Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Andhra Pradesh, India.
authors.forename: Pavan Kumar S R
authors.initials: PK
authors.lastname: Kothapalli
authors.affiliation: Aurobindo Pharma Ltd Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Andhra Pradesh, India.
authors.forename: Madhava Reddy
authors.initials: MR
authors.lastname: Peddolla
authors.affiliation: Aurobindo Pharma Ltd Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Andhra Pradesh, India.
authors.forename: Pradeep
authors.initials: P
authors.lastname: Rajput
authors.affiliation: Aurobindo Pharma Ltd Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Andhra Pradesh, India.
authors.forename: Hemant Kumar
authors.initials: HK
authors.lastname: Sharma
authors.affiliation: Aurobindo Pharma Ltd Research Centre-II, Survey No: 71 & 72, Indrakaran village, Sangareddy mandal, Medak district, 502329, Andhra Pradesh, India.
authors.forename: Shankar Reddy
authors.initials: SR
authors.lastname: Budeti
authors.affiliation: Andhra University College of Engineering, Visakhapatnam-530003, Andhra Pradesh, India.
authors.forename: Himabindu
authors.initials: H
authors.lastname: Gandham
authors.affiliation: Andhra University College of Engineering, Visakhapatnam-530003, Andhra Pradesh, India.
authors.forename: Annapurna
authors.initials: A
authors.lastname: Nowduri
keywords: Allylamine; Gas chromatography with Flame ionization detector; Sevelamer carbonate; Sevelamer hydrochloride