STABILITY INDICATING OPTIMIZED RP-HPLC METHOD APPLYING QBD PRINCIPLES FOR QUANTITATIVE ESTIMATION OF NIMORAZOLE

ICH Q8(R2) guidelines concerning the development of pharmaceutical process following a Quality by Design (QbD) approach can be implemented for analytical method developments. Nimorazole is a hypoxic radiosensitizer used in radiotherapy treatment for squamous cell cancer of the head and neck. The aim of the present work was to develop a simple, robust, optimized and stability indicating reverse phase high performance liquid chromatographic method underlying QbD principles for the estimation of nimorazole in pharmaceutical samples. The objectives were achieved at optimized chromatographic conditions using a column of dimensions, 250 x 4.6 mm, C18 (5 μm) (such as Sunfire C18), using mobile phase comprising a mixture of 51 volumes of 0.01 M KH2PO4 solution and 49 volumes of methanol using flow rate of 1.0 mL per minute, injection volume of 10 μl, column oven temperature at 27°C and 302 nm as detection wavelength. The developed method was found linear over the concentration range of 10-150 ppm with detection and quantitation limit of 2.73 ppm and 8.28 ppm respectively. The retention time of nimorazole is found about 4.9 minutes and the assay observed were 101.60 % and 99.52 % in bulk drug and tablet dosage form respectively. Whilst performing the forced degradation studies to demonstrate the specificity of analytical method, nimorazole suffers much degradation in oxidative, less in basic and least in acidic conditions, while no degradation was observed in thermal and photolytic conditions. The respective degradation products were well resolved from the pure drug. Hence, the method can be successfully employed for quantitative analysis of nimorazole in pharmaceutical samples.