Development and Validation of a Dissolution Test for Meloxicam and Pridinol Mesylate from Combined Tablet Formulation

Abstract

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.

Validation of Simultaneous Volumetric and HPLC Methods for the Determination of Pridinol Mesylate in Raw Material

“…The improved dissolution of pridinol mesylate at lower pH is probably due to the protonation of the piperidinic nitrogen (pKa = 9.7) [8]. The anionic titrant interacts with the positively charged pridinol to form ion-pair or ion-associate complexes which are extractable into organic solvents.…”