Self-modeling curve resolution method applied for the evaluation of dissolution testing data: A case study of meloxicam-mannitol binary systems

摘要

This paper introduces some chemometric methods, i.e., self-modeling curve resolution (SMCR), multi-variate curve resolution-alternating least squares (MCR-ALS) and parallel factor analysis (PARAFAC andPARAFAC2), which are used to evaluate in vitro dissolution testing data detected by a UV-vis spectropho-tometer on meloxicam-mannitol binary systems. These systems were chosen because of their relativesimplicity to apply as part of the validation process illustrating the effectiveness of the developed andapplied chemometric method. The paper illustrates the failure of PARAFAC methods used before for phar-maceutical data evaluations as well, and we suggest application of the feasible band form given by SMCRas a more general procedure.Steps to improve the dissolution behavior of drugs have become among the most interesting aspects ofpharmaceutical technology, and our results show that a larger particle size of meloxicam is advantageousfor dissolution. Instead of the use of only one characteristic wavelength, appropriate chemometric meth-ods can furnish more information from dissolution testing data, i.e., the individual dissolution rate profilesand the individual spectra for all the components can be obtained without resorting to any separationtechniques such as HPLC.