Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SITAGLIPTIN AND ERTUGLIFLOZIN IN BULK AND DOSAGE FORM

Aarati Sonawane*

ABSTRACT

A quick, responsive and economic high performance liquid chromatographic approach has been developed and validated for the detection of sitagliptin and ertugliflozin. For the RP-HPLC procedure, an Agilent gradient system UV detector and a C-18 column with a 100mm x 4.6 mm inner diameter and a 5 μm particle size were utilized. The mobile phase consisted of methanol and water with 0.1% OPA in 20:80 ratios. The wavelength of detection was 236 nm, and the pump flow rate was 0.7 ml/min. In the developed of HPLC method, the Sitagliptin and Ertugliflozin retention times were determined to be 3.5 minutes and 6.3 minutes, respectively. The method was validated in accordance with ICH guidelines. Linearity, range, precision, accuracy and robustness were within ICH-specified limits. The method was found to be easy, precise, accurate, cost-effective, and reproducible.

Keywords: Sitagliptin, Ertugliflozin, RP-HPLC method development and validation.