Author(s): Nagamalleswari Gampa, Naga Thirumalesh Chevala, 1Pracheet Pinnamaneni, 1Arulsamy Elphine Prabahar, 1Venkata Suresh Ponnuru, Rama Rao Nadendla
The current research concern about the development of stereo specific normal phase high performance liquid chromatographic method for the separation and estimation of enantiopurity of anagliptin (AGT) by using Lux cellulose- 3 [cellulose tris (4- benzoate)] chiral column, n- Hexane, ethanol and triethylamine (TEA) (80:20:0.5 v/v/v) solvent ratios were used as mobile phase at flow rate of 1ml/min in isocratic mode. Both AGT- (R) (desired form) and AGT- (S) (undesired form) detected at 254 nm with retention time of 9.11 min and at 8.09 min respectively, and having correlation coefficient (R2) of 0.999. Inter day and intraday precision of the developed method was < 1.0 % RSD and % mean recovery was found to be 99.074. Enantioselective method was validated for linearity, precision, accuracy, limit of detection & quantification, solution stability, robustness and ruggedness, developed method can be used for the separation and estimation of enantiopuirty of AGT- (R) in recemate mixture.