No abstract

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.

Aims: Novel green analytical methods have been proposed for the assay of Rabeprazole sodium and Fluvastatin sodium in their pure and formulated dosage forms. Study Design: The methods determine each drug through the estimation of its sodium content, using Flame Atomic Absorption Spectroscopy at wavelength 589 nm.  Place and Duration of Study: Central laboratory at Faculty of Pharmacy, Damanhour University. Time duration January-March, 2020. Methodology: Methods are developed and optimized for maximum sensitivity, selectivity and degree of greenness. Linearity is achieved in the range of 8.29- 66.33 ppm of Rabeprazole sodium (equivalent to 0.5- 4 ppm Na) and 14.13- 141.32 ppm of Fluvastatin sodium (equivalent to 0.75 -7.5 ppm Na). The proposed assays are fully validated regarding ICH guidelines.  Results: Atomic spectroscopic assays are compared to reported spectrophotometric ones for each drug separately using Student t-test and F-variance ratio.  Conclusion: Satisfactory values indicate good agreement and the insignificant difference between both methods. The obtained percentages of recovery (99-101%) indicate no interference from excipients in formulation matrices.