Abstract

STABILITY INDICATING RP – HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF REMOGLIFLOZIN ETABONATE AND TENELIGLIPTIN IN TABLET DOSAGE FORM

Rutvik R. Deshani*, Nilesh K. Patel, Urvi J. Chotaliya, Ashok B. Patel, Ajay I. Patel, Amitkumar J. Vyas

ABSTRACT

A specific, precise, accurate, cost-effective, and isocratic stability-indicating RP-HPLC method was developed and validated for quantitative analysis of Remogliflozin Etabonate (REMO) and Teneligliptin (TEN) in a tablet dosage from in the presence of its degradants. Separation was achieved by using Hypersil BDS C18 (250 mm×4.6 mm, 5 µm) column, utilizing a mobile phase composition of phosphate buffer pH 5.5: acetonitrile (50:50 %v/v) at a flow rate of 1 mL/min, injection volume 10 µL with the detection at 224 nm. REMO and TEN were eluted with retention times of 3.11 min and 4.75 min, respectively. This method was validated as per the ICH guideline (Q2R1). The calibration plots were over the concentration range of 100-300 μg/mL and 10 - 30 μg/mL for REMO and TEN with the correlation coefficients of 0.9986 and 0.9991, respectively at the two concentration ranges. Accuracy was obtained between 99.56 to 100.76 % and 99.73 to 101.29 %, for REMO and TEN, respectively for the two ranges tested. The limit of detection was found to be 1.125 μg/mL and 0.852 μg/mL and the limit of quantitation were found to be 3.410 μg/mL and 2.582 μg/mL for REMO and TEN, respectively. The results showed that the developed method is suitable for the routine analysis of REMO and TEN combinations in a tablet dosage form.

Keywords: Remogliflozin Etabonate, Teneligliptin, Stability indicating method, RP- HPLC, Tablet dosage form, ICH (Q2R1) guideline.