Abstract

Most relevant analytical technique has been established for the simultaneous quantification of rosuvastatin and teneligliptin in its specific and formulation utilizing reverse phase high performance liquid chromatography. The developed method was found to be linear, accurate, precise, robust and rugged. The mobile phase used was acetonitrile:water (65:35) with flow rate of 0.8 ml/min. The pH was set to 2.5 using orthophosphoric acid. The elution time obtained were 5.48 min for rosuvastatin along with 2.35 min for teneligliptin. The smallest amount of analyte which can be detected and quantified considered being 7.58 µg/ml and 22.98 µg/ml for rosuvastatin and 6.96 µg/ml and 21.10 µg/ ml for teneligliptin subsequently. Every single estimated parameters complied with the relevant criteria, therefore specified the usefulness of reverse phase liquid chromatographic method for quantification of tablet dosage form. Forced degradation studies have been performed using the developed method. Degradation of rosuvastatin was performed under photoalkaline condition and degradation of teneligliptin under photoacidic condition. Structural characterization tools such as fourier transform infrared, nuclear magnetic resonance and electron spray ionization mass spectrometer were used for depiction of degradation products. The fragmentation pathways of both the drugs were depicted. Additionally, in silico toxicity of the degradants was predicted using ProTox-II software. This investigation indicates an extensive new method for degradation studies which can be useful in the course of drug development phase.