Development and validation of RP-HPLC method for simultaneous estimation of Ertugliflozin and Sitagliptin in bulk drug and tablet dosage form
Journal Title: International Journal of Experimental Research and Review - Year 2023, Vol 32, Issue 3
Abstract
To treat type 2 diabetes, in a combined tablet dosage form the ertugliflozin and sitagliptin were administered. Considering the less complication and readily availability of HPLC, the main objective of present study was to develop a new, precise, accurate, linear, robust, and economical RP-HPLC method for the simultaneous estimation of ertugliflozin and sitagliptin in tablet dosage form. Effective chromatographic separation of Ertugliflozin and Sitagliptin was achieved on Kromasil C18 (5 µm 250 mm X 4.6 mm) and the mobile phase containing Methanol and 0.1% OPA in water isocratic elution mode at a flow rate of 1.0mL/min. with column temperature at 30 °C and the injection volume was 20 µL at column temperature at 30°C. At an isosbestic wavelength of 212 nm, ertugliflozin and sitagliptin were found to have retention times of 5.30 min. and 2.05 min., respectively. The method was proven to be precise (%RSD 2%), accurate (>90%), and specific for the simultaneous measurement of both drugs in tablets. As a result, the suggested method with excellent specificity, accuracy, precision, linearity and robustness as well as economical was useful for the regular quality control analysis of ertugliflozin and sitagliptin tablets.
Authors and Affiliations
S. D. Mankar, Priyanka Sagar, Sanjay Bhawar, Suhas Siddheshwar, Santosh Dighe
Keywords
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- EP ID EP720675
- DOI 10.52756/ijerr.2023.v32.025
- Views 36
- Downloads 0
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