HPLC Method Development and Validation for Sitagliptin and Ertugliflozin in Bulk and Dosage Forms

Abstract

A novel and robust analytical method has been developed and validated for the simultaneous estimation of Sitagliptin and Ertugliflozin in bulk and dosage forms using high-performance liquid chromatography (HPLC) (1).The method employs a UV detector for detection at a wavelength of 212 nm. The chromatographic separation was achieved using an Agilent Poroshell C18 column (150 mm × 4.6 mm i.d., 5 μm particle size) with a mobile phase composed of Acetonitrile and water in a 60:40 ratio. The flow rate was set to 1.0 ml/min, and the column oven was maintained at 35°C to ensure optimal separation (2). The injection volume was 20 μL, and the analysis was carried out at a wavelength of 212 nm, ensuring precise quantification of both Sitagliptin and Ertugliflozin in the pharmaceutical dosage form and bulk drug substance. The developed method demonstrates excellent resolution and sensitivity, making it suitable for routine analysis in quality control laboratories (3, 4). Method validation was performed according to ICH guidelines, evaluating parameters such as linearity, precision, accuracy, and specificity, limit of detection (LOD), limit of quantification (LOQ), robustness, and system suitability. The method proved to be reliable, accurate, and precise, offering a suitable solution for the simultaneous analysis of Sitagliptin and Ertugliflozin in both bulk and dosage forms. This validated analytical method is expected to be highly effective in ensuring the quality and consistency of pharmaceutical formulations containing Sitagliptin and Ertugliflozin (5).