A simple and rapid high-performance liquid chromatography method to quantify and evaluate the purity of nicotine in solution and in microspheres

A simple isocratic technique was developed for the analysis Of nicotine hydrogen tartrate using high-performance liquid chromatography it with UV detection. Nicotine was separated from its main degradation products (cotinine, nicotine-1'-oxide, nicotinic acid) on a special C-18 reverse-phase column. The quantitative analysis of nicotine was characterized with respect to specificity, linearity, accuracy and precision, and showed a good intra-dry and inter-day precision and accuracy (RSD < 2.5%). Nicotine concentration in solution, in a nasal spray formulation and in Sephadex microspheres (G25 and G50) was followed over a period of 5 months under different conditions of temperature and light. The study showed a slight loss of nicotine concentration (< 5%) in solution and in spray after 5 months; solutions exposed to light displayed a pale yellow coloration. The nicotine concentration in the microspheres did not significantly vary. None of the above mentioned main degradation products of nicotine were detected in this stability study.