title: Validated high-throughput HPLC assay for nimesulide using a short monolithic column.
abstract: 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 x 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 60s 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.
authors.affiliation: Quality Control Department, Cosmopharm Ltd., P.O. Box 42, Korinthos 20100, Greece. paristzanavaras@gmail.com
authors.forename: Paraskevas D
authors.initials: PD
authors.lastname: Tzanavaras
authors.forename: Demetrius G
authors.initials: DG
authors.lastname: Themelis
mesh_terms: D002021:Buffers; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D016861:Cyclooxygenase Inhibitors / Q000032:analysis*; D004340:Drug Contamination; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012995:Solubility; D013449:Sulfonamides / Q000032:analysis*; D013607:Tablets; D013997:Time Factors
chemical_list: D002021:Buffers; D016861:Cyclooxygenase Inhibitors; D013449:Sulfonamides; D013607:Tablets; C012655:nimesulide