Novel Simplified, New Analytical Method for Stress Degradation Study of Ertugliflozin an Oral Anti-diabetic Agent by RP-HPLC Method
Arulselvan Murugesan1* and Annapurna Mukthinuthalapati Mathrusri2
1Department of Pharmaceutical Analysis, AIKTC School of Pharmacy, India
2Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India
*Corresponding Author: Arulselvan Murugesan, Department of Pharmaceutical Analysis, AIKTC School of Pharmacy, India.
September 21, 2021; Published: November 10, 2021
Precise, simple and Stability indicating RP-HPLC method was developed and validated for Ertugliflozin in this study. Major objective of this proposed method for Ertugliflozin validated as per the guidelines of ICH and FDA. The following parameters were validated according to ICH guidelines in terms of System suitability, Solution stability, Linearity, Accuracy, Precision, Robustness and Stress degradation studies. In this proposed method, the separation was carried out using C18 Hypersil ODS Column (250 mm x 4.6 mm, 5 µm) with isocratic flow and the mobile phase utilized was acetate buffer and acetonitrile 60:40 (v/v). Ertugliflozin peaks were identified and separated at UV detection wavelength 240 nm. The pH of acetate buffer was adjusted to 4.0 with O-Phosphoric acid. The retention time for Ertugliflozin was found to be 2.30 ± 0.04 min. The results were found linear with concentration range 2.5 to 50 µg/ml (r2 = 0.9998). The % recovery for the developed method found 98.48 to 99.43% for Accuracy and Precise for Intra and Interday method. No deliberate variation found for our developed method in flow rate, mobile phase and detection wavelength. The precision report for various concentrations (5 µg/ml, 7.5 µg/ml and 10µg/ml) found to be less than 2% for Intra and Interday precision. In forced degradation studies, Ertugliflozin was stable in Acidic, Alkaline, Thermal conditions whereas in Photolytic and oxidative conditions notable degradation was observed. The RP-HPLC method was validated according to ICH and FDA guidelines. The developed method was found to be Specific, precise, simple, sensitive, accurate, linear and thus to be considered stability indicating for Ertugliflozin pharmaceutical formulations and research tablets.
Keywords: Ertugliflozin; RP-HPLC; Stability Indicating; T2DM; SGLT2; ICH; USFDA
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