Фармацевтика Аналитика Акта

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Eco-Friendly HPTLC Method for Simultaneous Analysis of Simvastatin and Ezetimibe in Pharmaceutical Preparations and Trying to Use Limonene as Eluent

Eldin AB, Ismaiel OA, Hassan WE and Shalaby AA

In this study, a simple, rapid, sensitive and green High Performance Thin Layer chromatography (HPTLC) method was developed and validated for determination of Simvastatin and Ezetimibe in tablet dosage form. The method was carried out in TLC silica gel of nano particle size on glass plate 60 F 254, 10 cm ×10 cm. Two solvent systems were chosen according to the Green Analytical Chemistry (GAC) parameters. Acetone: Heptane: Isopropyl alcohol in the proportion of 10:10:5, (v/v/v) with Rf Value for Simvastatin and Ezetimibe was 0.513 and 0.312 respectively. The linear regression coefficients were 0.999 and 0.998 for Simvastatin and Ezetimibe with respect to peak area and height in the concentration range of 600 - 1500 ng/spot and 150 - 375 ng/spot respectively. To get greener solvent, heptane was replaced with limonene in the second elution system but this system could separate either Simvastatin or Ezetimibe solely in single preparations but could not separate both of them simultaneously because both of them has almost the same Rf. The linear regression coefficients were 0.998 and 0.995 for Simvastatin and Ezetimibe respectively with the same concentration range of the first system. TLC plates of nano sized particles offer sharper separations due to small particle size and narrow fractionation. Theoretical plate heights (h values) are considerably smaller than those of the standard TLC plate. In addition diffusion and – as a consequence -band broadening are much lower. Also shorter developing times and shorter migration distances: After only a few centimeters an optimal separation has been achieved. Smaller samples of 0.01-0.1 μl (10-100 nanoliters). The samples applied are considerably smaller than with standard plates, thus it is possible to apply a large number of samples to a very small surface area, without samples interfering with each other. Finally increased detection sensitivity (nanogram level, hence nano plate). With fluorescence evaluation pico-gram quantities can be detected