Systematic Development and Validation of Analytical Techniques for Simultaneous Quantification of Ertugliflozin and Metformin Hydrochloride in Bulk and Pharmaceutical Formulations

Abstract

To evaluate Simultaneous Quantification of Ertugliflozin and Metformin Hydrochloride in Bulk and
Pharmaceutical Formulations, a quick, reliable and consistent method was developed. The drugs were injected in
to the inertsil C18 (250 x 4.6 mm) maintained at room temp and wavelength 220 nm. The mobile phase consists of
buffer (potassium dihydrogen pH 4.0) and methanol (65:35 v/v). The flow rate is maintained at 1.0 mL/min. The
calibration curve was linear and regression co-efficient (R2) value was found to be 0.999 and concentration ranging
from 1.5-4.5 µg /mL and 100-300 µg/mL for Ertugliflozin and Metformin hydrochloride respectively. The LOD and
LOQ of the method were found 1.04 μg /mL, 9.61 μg/mL and 0.0007 μg/mL, 0.006 μg/mL for Ertugliflozin and
Metformin HCl. The developed method was found to be simple, precise, specific, linear and accurate as validated
as per USP and International Conference on Harmonization (ICH) guidelines. In all condition’s purity threshold
was more than purity angle and within the acceptable range. This approach that can be used in industry in a daily
quality assurance process became easy and economical.