Development and Validation of a Stability-Indicating RP-UPLC Method for the Quantitative Analysis of Nabumetone in Tablet Dosage Form

• Published in: Journal of chromatographic science Vol. 50; no. 2; pp. 85 - 90
• Main Authors: Sethi, Neha, Anand, Ankit, Chandrul, Kaushal K., Jain, Garima, Srinivas, Kona S.
• Format: Journal Article
• Language: English
• Published: Niles, IL Oxford University Press 01.02.2012; Preston Publications
• Subjects: Analysis; Biological and medical sciences; Butanones - analysis; Chromatography, Liquid - methods; Cyclooxygenase 2 Inhibitors - analysis; Dosage Forms; General pharmacology; Limit of Detection; Medical sciences; Pharmacology. Drug treatments; Reference Standards; Reproducibility of Results; Tablets; Validation; Ultra performance liquid chromatography; Prostaglandin-endoperoxide synthase; Chemical analysis; Enzyme; Chemical stability; Enzyme inhibitor; Oral form; Isocratic condition; Thermal stability; Non steroidal antiinflammatory agent; Nabumetone; Reversed phase chromatography; Analgesic; Ultraviolet detector; Storage stability; Quality control; Antipyretic; Dosage form; Photochemical stability; Tablet; Oxidoreductases; Quantitative analysis
• ISSN: 0021-9665; 1945-239X
• DOI: 10.1093/chromsci/bmr001

High efficiency and less run time are the basic requirements of high-speed chromatographic separations. To fulfill these requirements, a new separation technique, ultra-performance liquid chromatography (UPLC), has shown promising developments. A rapid, specific, sensitive, and precise reverse-phase UPLC method is developed for the determination of nabumetone in tablet dosage form. In this work, a new isocratic chromatographic method is developed. The newly developed method is applicable for assay determination of the active pharmaceutical ingredient. The chromatographic separation is achieved on a Waters Acquity BEH column (100 mm, i.d., 2.1 mm, 1.7 µm) within a short runtime of 2 min using a mobile phase of 5 mM ammonium acetate-acetonitrile (25:75, v/v), at a flow rate of 0.3 mL/min at an ambient temperature. Quantification is achieved with photodiode array detection at 230 nm, over the concentration range of 0.05-26 µg/mL. Forced degradation studies are also performed for nabumetone bulk drug samples to demonstrate the stability-indicating power of the UPLC method. Comparison of system performance with conventional high-performance liquid chromatography is made with respect to analysis time, efficiency, and sensitivity. The method is validated according to the ICH guidelines and is applied successfully for the determination of nabumetone in tablets.