Development and Validation of HPTLC Method for Nabumetone from Pharmaceutical Dosage Form

Abstract:

A simple, rapid, reliable and accurate HPTLC method has been developed for the estimation of Nabumetone in pharmaceutical dosage form. The drug was extracted from (NILTIS* 500). Various aliquots of this sample solution were spotted automatically by means of Camag (Muttenz, Switzerland) Linomat V applicator on Merck HPTLC plates (10.2 mm thickness) precoated with silica gel 60 F on aluminum sheet as stationary 254 phase prewashed with methanol using toluene:acetonitrile:triethylamine 9.5:0.5:0.1 (v/v/v) as mobile phase. The spots were scanned at λ=229 nm using Camag TLC scanner 3. The R value of Nabumetone was 0.54. Calibration curves were linear in the range of 200-1200 f ng/spot with regression coefficient of 0.999. The limit of detection and quantitation were found to be 15.59 and 47.27 respectively. The suitability of this method for quantitative determination of compound was proved by validation in accordance with requirement of pharmaceutical regulatory standards.Therefore this proposed method was applied for routine analysis of this drug in pharmaceutical dosage form.

Keywords: Nabumetone, HPTLC, Pharmaceutical dosage form.