Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE, LINAGLIPTIN AND METFORMIN HYDROCHLORIDE IN TABLET DOSAGE FORM

*Maahi Prajapati, Dr. Priyanka Yadav and Devanshi Trivedi

ABSTRACT

Dapagliflozin Propanediol Monohydrate, Linagliptin and Metformin Hydrochloride Tablet is prescribed for managing used to reduce the blood sugar level. Dapagliflozin Propanediol Monohydrate is used improved glucose control and even weight loss to this excretion. Linagliptin used for liver's breakdown of glycogen and increase the release of insulin in response to glucose. Metformin Hydrochloride used by reducing intestinal glucose absorption, hepatic glucose synthesis and peripheral glucose uptake raises insulin sensitivity. This study focuses on validating an HPLC method for the simultaneous estimation of dapagliflozin propanediol monohydrate, linagliptin and metformin hydrochloride. The validation parameters include specificity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) and robustness. The chromatographic analysis was performed using an Agilent Zorbax SB-CN (250 mm x 4.6 mm x 5 μ). The mobile phase consisted of a buffer-to-methanolratio of 55:45 (% v/v) at a flow rate of 0.9 mL/min. Detection was carried out using a UV detector at a wavelength of 228 nm, with the column oven maintained at 25°C and an injection volume of 10 μL. The developed method was found to be precise, accurate, linear, robust, and sensitive. Furthermore, it demonstrated successful applicability for the determination of Dapagliflozin Propanediol Monohydrate, Linagliptin and Metformin Hydrochloride in Tablet dosage form.

Keywords: Dapagliflozin Propanediol Monohydrate, Linagliptin, Metformin Hydrochloride, HPLC, Method Validation.