Abstract

STABILITY INDICATING ANALYTICAL METHOD AND VALIDATION FOR ESTIMATION OF REMOGLIFLOZIN ETABONATE IN BULK & DOSAGE FORM USING UPLC

*Mariyam Naaz and Dr. SH. Rizwan

ABSTRACT

In the present investigation, the wavelength of maximum absorption (λ max) of the solution of the drug in mobile phase were scanned using UV-Visible spectrophotometer within the wavelength region of 200–400 nm against methanol as blank Remogliflozin was selected as detector wavelength for the UPLC chromatographic method. The proposed method is new, simple, environmentally friendly, accurate, reproducible, precise and validated statistically for stability indicating method and validation for simultaneous estimation of remogliflozin etabonate in bulk & pharmaceutical dosage form. The Remogliflozin peak was observed at 2.818 mins with good efficiency (>2000) and peak shape and good resolution and tailing factor (< 2). All the method parameters like Accuracy, system suitability, method precision, linearity and range, LOD,LOQ, Robustness & Ruggedness show good results which was validated stastically. The proposed method was established to be precise and stability indicating as no interfering peaks of degrades and excipient was observed. The proposed method is therefore suitable for purpose in quality-control laboratories for quantitative analysis of the drug individually, as it is simple and rapid.

Keywords: Remogliflozin etabonate, stability indicating,UPLC, parameters, validation, drug.