Optimization and validation of RP HPLC Method Development on Trelagliptin Succinate

A simple, precise, accurate and stability-indicating RP-HPLC method was developed and validated for the estimation of Trelagliptin Succinate from tablet. In the present study RP - HPLC method, Agilent (Autosampler) Gradient System DAD Detector and C18 (Agilent) column with 250mm x4.6 mm i.d and 5μm particle size was used. Acetonitrile: Water 0.1 % Acetic  acid (65:35v/v) pH 3.0 was used as the mobile phase for the method.  The analysis of Trelagliptein succinate in methanol using UV spectrophotometric analysis yielded a well-defined peak absorption maximum (λ max) which showed that it could be detected analytically. The detection wavelength was 278 nm and flow rate was 0.8 ml/min. The chromatographic conditions were optimized based on systematic trials on varying mobile phase compositions.In the developed method, the retention time of Trelagliptin Succinate were found to be 3.9 min.  The method had a high linearity in 5-25 μg/mL concentration range with a regression equation of y = 49.78x – 43.516 correlation coefficient (R 2) of 0.999 indicating a good linear relationship between concentration and peak area. The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. The developed method was found to be simple, accurate, precise, economic and reproducible. Intraday and interday precision studies also demonstrated a very low level of the values of %RSD, below 2%, indicating outstanding repeatability and reproducibility of the method. The LOD of Trelagliptin succinate was found to be 0.1246 (μg/mL) indicate the analytical methods was concluded.The LOQ of Trelagliptin succinate was found to be 0.3776(μg/mL) analytical method that validated.Analysis of marketed formulation  % Lable Claim was found to be 98-101% ,satisfactory and are accepted. So, it is worthwhile that, the proposed methods can be successfully utilized for the routine quality control analysis Trelagliptin Succinate in bulk drug as well as in formulations.