Estimation of Teneligliptin in Oral Solid Dosage Form by Reverse Phase Chromatographic Technique Using HPLC (Research Article)

Author(s): R. Narsimha Rao, P. Sandhya, N. Karnakar and P. Amani

Abstract: A new method was established for estimation of Teneligliptin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Teneligliptin by using Agilent column (4.6×150mm) 5μ, flow rate was 1.0 ml/min, mobile phase ratio was Phosphate buffer: meoH (25:75% v/v), detection wavelength was 270nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.182 mins. The % purity of Teneligliptin was found to be 98.56%. The system suitability parameters for Teneligliptin such as theoretical plates and tailing factor were found to be 4343.2, 1.6. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Teneligliptin was found in concentration range of 20μg-100μg, and correlation coefficient (r2) was found to be 0.999, % recovery was found to be 98.96%, %RSD for repeatability was 0.3, % RSD for intermediate precision was 0.8. The precision study was precision, robustness, and repeatability. LOD value was0.439 and LOQ value was 1.466.

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