Thursday , 22 February 2024

Analytical Method Development and Validation for the Simultaneous Estimation of Teneligliptin and Metformin by RP-HPLC Method

Annam Naga Durga Lakshmi Rishitha1*, Gope Edward Raju2, Vaddi Lakshmi Priya3, Doonaboyina Raghava4, Kavala Nageswara Rao5
Department of Pharmaceutical Analysis, K.G.R.L College of Pharmacy, Bhimavaram-534201, Andhra Pradesh, India

A B S T R A C T
A new method was established for simultaneous estimation of Teneligliptin and Metformin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Teneligliptin and Metformin by using X BRIDGE C18 column (4.6×50mm)3.7µ, flow rate was 1ml/min, mobile phase ratio was (40:20:40 v/v) methanol : Acetonitrile : phosphate buffer(KH2PO4and K2HPO4)phosphate pH 3 (pH was adjusted with orthophosphoricacid), detection wavelength was 290nm. 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 2.191 mins and 3.868 mins. The % purity of Teneligliptin and Metformin was found to be 104.4% and 103.39% respectively. The system suitability parameters for Teneligliptin and Metformin such as theoretical plates and tailing factor were found to be 993, 1.23 and 5775, 1.12, the resolution was found to be 10.18. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Teneligliptin and Metformin was found in concentration range of 50µg-250µg and 5µg-25µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %RSD for repeatability was 0.1 and 1.4, % RSD for intermediate precision analyst 1 was 0.5 and 0.6 and intermediate precision analyst 2 was 0.4 and 0.4 respectively. The precision study was precision, robustness and repeatabilty. LOD value was 0.39 and 0.7 and LOQ value was 1.18 and 2.12 respectively.

Keywords: X BRIDGE C18 column, Teneligliptin and Metformin, RP-HPLC, Methanol.

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