Abstract
A reverse phase HPLC method using C 18 column has been developed for the quantitative estimation of nicotine in the bulk material and formulations (extended release and immediate release dosage forms). The method is specific to nicotine (RT ∼4.64 min, asymmetry ∼1.75), and can resolve analyte peak from excipient interferences. It is linear (coefficient of variation∼0.9993), accurate (average recovery ∼100%), and passed all the system suitability requirements. Applicability of the method was evaluated in analysis of drug-excipient compatibility samples, commercial dosage form (such as nicotine gum) and two novel in-house formulations.
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