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PubMed · 17118614

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

Paraskevas D Tzanavaras·Demetrius G Themelis
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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.

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BuffersChromatography, High Pressure LiquidCyclooxygenase InhibitorsDrug ContaminationDrug StabilityHydrogen-Ion ConcentrationReproducibility of ResultsSensitivity and SpecificitySolubilitySulfonamidesTabletsTime FactorsJournal Article

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Paraskevas D Tzanavaras, Demetrius G Themelis. 2006-11-21. Validated high-throughput HPLC assay for nimesulide using a short monolithic column.. https://doi.org/10.1016/j.jpba.2006.10.014

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