A validated high performance liquid chromatographic method for analysis of nicotine in pure form and from formulations.

A reverse phase HPLC method using C18 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 approximately 4.64 min, asymmetry approximately 1.75), and can resolve analyte peak from excipient interferences. It is linear (coefficient of variation approximately 0.9993), accurate (average recovery approximately 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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