Observation of nicotinic acid in nicorandil samples and simultaneous determination of nicorandil and its three degradation products in raw drug and tablet form by high performance liquid chromatography

Nicotinic acid (NA) as a degradation product of nicorandil (NIC) was identified and quantified by HPLC-DAD and GC / MS. In the present paper a rapid, sensitive, precise and specific HPLC-DAD method was developed for the simultaneous determination of NIC, NA and two known degradation products, nitrate (NI) and de-nitrated nicorandil N-(2-hydroxyethyl) nicotinamide] (HEN) in raw drug and tablet form. The present method was performed on an ODS C₁₈ column (150 × 4.6 mm, 5 μm) using detection at 204 nm and employing nicotinamide (NT) as internal standard. The procedure was validated by evaluating linearity, accuracy and recovery and applied to monitor the increased level of NI, HEN and NA as a function of NIC storage time at room temperature.