Monday , 27 February 2017

A Validated RP- HPLC Method for the Simultaneous Estimation of Empagliflozin and Linagliptin in its Bulk and Pharmaceutical Dosage Forms

Jayalaxmi1, Dr. T. Rajesh1, Dr. Gampa Vijaya Kumar*2
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2Professor and Head, Department 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 Empagliflozin and Linagliptin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Empagliflozin, Linagliptin by using Agilent C18 column (4.6×150mm) 5µ, flow rate was 1ml/min, mobile phase ratio was (70:30v/v) methanol: phosphate buffer (KH2PO4, K2HPO4) phosphate pH 3 (pH adjusted with orthophosphoricacid), wavelength was detected as 254nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Empagliflozin and Linagliptin was found in concentration range of 10µg-50µg and 20µg-100µg 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 1.2 and 2.0, % RSD for intermediate precision was 1.1 and 1.1 respectively. The precision study was precision, robustness and repeatabilty.LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively.

Keywords: Empagliflozin, Linagliptin, RP-HPLC, Agilent C18 column

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