Abstract
The USP HPLC method for quantitative determination of nevirapine in suspension formulations was evaluated to determine its ability to resolve nevirapine and its major related impurities. The method was modified and an overall satisfactory resolution for all components was obtained by changing the column temperature to 25 °C, the organic modifier to methanol, the mobile phase ratio to 50 %, adding 1 % HCl into the diluents, decreasing the flow rate from 1.5 to 1.2 mL mL−1 and using an isocratic mode. The related organic impurities were synthesized in high yield. The method is shown to be linear with coefficient of determination around 0.999 to nevirapine (Nvp) and related impurities were resolved using a mobile phase of potassium phosphate/phosphoric acid buffer (pH 2.5; 10 mM): methanol (50:50, v/v) on a BDS Hypersil C18 5 μm, 250 × 4.6 mm column. Accuracy ranged from 100.2 to 101.1 % and 100.0 to 100.5 % for nevirapine and related impurities, respectively. Repeatability from all experiments achieved RSD values <0.95 %. The detection and quantification limits were determined in the level of ng mL−1. This method easily separated all known impurities synthesized and can be employed for routine analysis of suspension containing nevirapine in the presence of its impurities.
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