Validated green micellar electrokinetic capillary chromatography for simultaneous determination of simvastatin and sitagliptin phosphate binary mixture in pharmaceutical formulation

• Published in: Separation science plus Vol. 5; no. 2; pp. 40 - 49
• Main Authors: Kamal, Miranda F., Morshedy, Samir, Saad, Dina A., Moneeb, Marwa S.
• Format: Journal Article
• Language: English
• Published: 01.02.2022
• Subjects: diabetic dyslipidemia; green chemistry; micellar electrokinetic chromatography
• ISSN: 2573-1815; 2573-1815
• DOI: 10.1002/sscp.202100042

Diabetics are liable to fatal atherosclerotic cardiovascular diseases. It is clinically attributed to their imbalanced plasma lipoproteins. Fixed‐dose combination “polypill” of simvastatin (10 mg) and sitagliptin phosphate (100 mg) is mainly indicated for the treatment of diabetic dyslipidemia. Novel green micellar electrokinetic capillary chromatographic method has been developed for simultaneous determination of simvastatin and sitagliptin phosphate in binary synthetic mixtures and their pharmaceutical formulation. Separation was achieved using a deactivated fused silica capillary (50 cm effective length × 50 μm id) through a background running electrolyte of 100 mM borate buffer (pH 9.1) and 100 mM sodium dodecyl sulfate. Diode array detection was set at 238 and 210 nm for simvastatin and sitagliptin phosphate, respectively. All experimental parameters were closely varied and optimized. Both drugs declared good linearities over the range of 10–100 μg/mL. Proposed study was validated according to International Council for Harmonization guidelines. It was applied to the assay of laboratory‐made binary mixtures and marketed tablets. Electrophoretic assay was compared with a reported spectrophotometric one. Satisfactory t‐test and F‐ratio indicated insignificant differences between both methods. Moreover, it is the first capillary electrophoretic simultaneous assay for simvastatin and sitagliptin phosphate, and fits a linear correlation with the green analytical attributes.