Validated high-throughput HPLC assay for nimesulide using a short monolithic column

High samples analysis rate is a key demand in modern pharmaceutical analysis, especially during new product development and validation of industrial-scale manufacturing process. The present study reports a validated HPLC assay for the dissolution studies of nimesulide-containing tablets (Lizepat® 100 mg/tab, Cosmopharm Ltd., Korinthos, Greece). Using a 50 mm × 4.6 mm i.d. monolithic column (Chromolith®, Merck) and acetonitrile-phosphate buffer (pH 7.0; 10 mM) (34:66, v/v) as the mobile phase, the separation cycle was completed in 60 s at a flow rate of 4.0 ml min−1. The assay was validated in terms of selectivity against potential impurities of the active ingredient, detection and quantification limits, linearity, accuracy and inter-/intra-day precision. Results from the application of the HPLC method to the accelerated and long-term dissolution stability control of Lizepat® tablets (Lot 005) are reported.