ABSTRACT

A simple, fast and accurate Reverse Phase High Performance Liquid Chromatography method has been established and validated for estimation of rosuvastatin and teneligliptin in their synthetic mixture. The chromatographic separation was achieved on Agilent Inertsil Octa Decyl Silane (ODS) C18 (250 × 4.6 mm, 5 µm) column using mobile phase composition of methanol: water (pH=3 adjust with 10 % Orthophosphoric acid) (70:30 V/V), in isocratic mode at flow rate of 0.8 mL min-1 at a detection wavelength of 244 nm. In terms of precision, accuracy, limit of detection and limit of quantitation, the method was validated. Rosuvastatin and teneligliptin had retention times of 7.41 and 4.35 minutes, respectively. Rosuvastatin and teneligliptin were reported to have linearity of 5-15 µg mL-1 and 10-30 µg mL-1, respectively, with correlation coefficient (R2 ) value of 0.998 for rosuvastatin and 0.999 for teneligliptin. Method can be employed for study of rosuvastatin and teneligliptin in their mixture.