Development and Validation of a GC-HS Method for the Estimation of Allylamine in Sevelamer Hydrochloride Tablets Dosage Form

A sensitive static headspace gas chromatographic method using flame ionization detector was developed and validated for the estimation of Allylamine in Sevelamer hydrochloride tablet dosage form. The chromatographic separation was achieved on capillary column Rtx-5 Amine (30m×0.53mm×1.0μm) with 5% diphenyl/95% dimethyl polysiloxane stationary phase. The critical experimental parameters such as, diluents, columns and sample preparations were studied and optimized. The method was validated as per United States Pharmacopoeia (USP) and International Conference on Harmonization (ICH) guidelines in terms of detection limit, quantification limit, linearity, precision, accuracy, specificity, solution stability and robustness. The method was found to be linear in the range between 10 μg/mL and 75 μg/mL with a correlation coefficient (r2) of 0.99984. The detection and quantification limits obtained for Allylamine were 3.3 μg/mL and 10.0 μg/mL w.r.t sample concentration respectively. The recovery obtained for Allylamine was between 100.0% and 110.0%. The developed method was applied successfully for the estimation of Allylamine in Sevelamer hydrochloride tablet dosage form.