Monday , 24 February 2020

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

P. Sai Veena1, Dr. G.Vijay Kumar2*
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A  B  S  T  R A C T
A new method was established for simultaneous estimation of Metformin and Sitagliptin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Metformin and Sitagliptin by using Symmetry C18 column (4.6×150mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol:phosphate buffer(KH2PO4and K2HPO4)  pH 3 ( pH was adjusted with orthophosphoric acid), detection wave length was 258nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The % purity of Metformin and Sitagliptin was found to be 100.27% and 99.87% respectively. The system suitability parameters for Metformin and Sitagliptin such as theoretical plates and tailing factor were found to be 2294, 1.27 and 4891 and 1.03, the resolution was found to be 8.67. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study Metformin and Sitagliptin was found in concentration range of 50µg-250µg and 5µg-50µg 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 0.27 and 0.40, % RSD for intermediate precision was 0.27 and 0.94 respectively. The precision study was precise, robust, and repeatable.LOD value was 2.17 and 6.60, and LOQ value was 0.032 and 0.1125 respectively.
Keywords: Symmetry C18, Metformin and Sitagliptin, RP-HPLC

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