Method I represented the first electro-driven separation method for the assay of this FDC using Micellar Electrokinetic Chromatography (MEKC). The latter was freshly prepared and then confirmed using Liquid Chromatography-Mass spectrometry (LC-MS). Within this framework, two validated analytical methodologies have been implemented for the neat separation and quantitation of metformin (MET) and rosuvastatin (RSV) in presence of the pharmacopeial impurities cyanoguanidine (CYG) (impurity A of MET) and the rosuvastatin-related substance B (RSV-impurity B). Generally, the beneficial outcomes of FDC in reduction of pills burden, cost and complexity of medications protocols, encouraged analysts and we in turn for the development of rapid sustainable analytical methods for the simultaneous estimation of such important drug combinations. Rosuvastatin-Metformin is an emerging fixed dose combination (FDC) for the treatment of diabetes mellitus-associated dyslipidemia.
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