Development and validation of a dissolution test for meloxicam and pridinol mesylate from combined tablet formulation

• Published in: Indian journal of pharmaceutical sciences Vol. 72; no. 2; pp. 197 - 203
• Main Authors: Vignaduzzo, S E, Castellano, P M, Kaufman, T S
• Format: Journal Article
• Language: English
• Published: India Medknow Publications and Media Pvt. Ltd 01.03.2010; Medknow Publications & Media Pvt. Ltd; Medknow Publications
• Subjects: Arthritis; Associations; Dissolution (Chemistry); Experiments; Meloxicam; Methods; Muscle relaxants; Quality control; Research Paper; Studies; Technological change; Testing; India; method validation; quality control of tablets; meloxicam; Dissolution test; pridinol mesylate
• ISSN: 0250-474X; 1998-3743
• DOI: 10.4103/0250-474X.65033

The association of meloxicam and pridinol is indicated for treating muscular contractures and low back pain. A dissolution test for the meloxicam-pridinol combined tablet formulation was developed and validated, using a suitable HPLC method for simultaneously quantitating both dissolved drugs. The optimized conditions include the use of USP apparatus 2 at a paddle rotation rate of 75 rpm and 900 ml of 50 mM phosphate buffer (pH= 7.5) as dissolution medium, at 37.0±0.5°. The test, which demonstrated to be robust against small changes in bath temperature, paddle rotation speed and pH of the dissolution medium, was applied to two different brands of tablets; the corresponding dissolution profiles were constructed and both brands showed to dissolve at least 75% of the drugs at the 45 min time point.