Analytical Method Development And Validation Of Impurity Profile In Semaglutide

Abstract

A simple analytical method for determination of impurity profile in Rifapentine developed and validated. The proposed method was developed by using Thermo BDS-Hypersil C18 (250mm × 4.6mm, 5µm) column at 25˚C with a mobile phase containing a gradient mixture of sodium di-hydrogen orthophosphate and acetonitrile with a run time of 55 min at monitored wavelength of 254nm. The method is developed for identification and quantification of related impurities in the API. The Stability-indicating capability of method is demonstrated by forced degradation of Rifapentine. The developed method is validated as per the guidelines of International Conference on Harmonization (ICH). The developed method is precise and is capable of detecting and quantifying all the known and unknown impurities. The proposed method is linear, sensitivity; accuracy and simple mobile phase imply that the method is suitable for quantification of related impurities in Rifapentine.