Development and validation of RP-HPLC analytical method for simultaneous estimation of Teneligliptin and Rosuvastatin in dosage form

Abstract

A new RP-HPLC method was developed for the estimation of teneligliptin and rosuvastatin in tablets and it was validated as per ICH guidelines. The chromatogram was found to be satisfactory on symmetry C-18 (4.6×250mm, 5µ Shim-Pack Solar column) using formic acid (pH 2.65) and acetonitrile in the ratio of 50:50 v/v at a flow rate of 1.0 ml/min. The retention time of teneligliptin and rosuvastatin were found to be 2.027 min and 7.787 min respectively at 265 nm. The system suitability parameters proved that the proposed method is suitable for simultaneous estimation of teneligliptin and rosuvastatin. Tailing factor for the peak was found to be 1.277 and 0.956 for teneligliptin and rosuvastatin respectively and the theoretical plates for separation were found to be 9397 and 153741 respectively for teneligliptin and rosuvastatin. The method was found to be linear in the range of 6-30 µg/ml for both the drugs. The precision of the method was good and the recovery of drugs is well within the acceptance limits of 80-120%. The LOD was found to be 2.257 µg/ml for teneligliptin and 2.338 µg/ml for rosuvastatin while the LOQ was found to be 6.840 µg/ml for teneligliptin and 7.086 µg/ml for rosuvastatin.