A Novel, stability indicating reversed phase ultra performance liquid chromatography (UPLC) method has been developed and validated for determination of Lorazepam (LP) related compounds in pharmaceutical dosage form. This chromatographic separation was carried out on an Acquity UPLC HSS T3 using reversed phase column (100 x 2.1mm, 1.8µm), a simple isocratic program for 10 minutes used. Mobile phase consists a mixture of water: Acetonitrile: Acetic acid in ratio of 50:42:1.2 (v:v:v), mobile phase flow rate used constantly at 0.50mL /minute. The chromatography analysis was monitored at 230nm with column oven temperature at 25 C and injection volume as 10µL. All the components were separated with good resolution in less than 10 minutes. The proposed method has been validated according to ICH guidelines, validation of method showed it to be Specific, Precise, Accurate, Robust, Rugged and Linear over a range of analysis. In literature survey, as far as we aware there was no UPLC method for quantitative estimation of LP degradation products along with potential impurities has been reported. The purpose of the present work was the development of a rapid, stability indicating UPLC method for the determination of LP related compounds in the pharmaceutical dosage forms and to establish the degradation pathway for LP along with its four potential impurities. The developed method was validated according to International Conference on Harmonization (ICH) guidelines [6]. Accordingly the aim of the present study is to establish degradation pathway of LP through stress studies under variety of ICH recommended test conditions. The results prove that the UPLC method is rapid, productive and cost effective for commercial analysis. Keywords
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