ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ERTUGLIFLOZIN AND METFORMIN HCl IN BULK AND PHARMACEUTICAL DOSAGE FORM BY HPLCAbstract
Analytical method for simultaneous estimation of Ertugliflozin (ERT) and Metformin hydrochloride (MET) was developed and validated by high-performance liquid chromatography (HPLC) as per ICH guidelines. The drugs were injected into the inertsil C18 (250 × 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 coefficient (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.
S. W. Shafaat *, A. Ahmed, G. J. Khan, S. Anas and A. A. Qureshi
Department of Quality Assurance, Ali-Allana College of Pharmacy, Akkalkuwa, Nandurbar, Maharashtra, India.
05 April 2019
16 September 2019
06 November 2019
01 January 2020