Development and Validation of Related Compounds Method for Lorazepam Tablets by Reverse Phase UPLC

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. Nomenclature and Units: mL: Milli Liter; Min: Minutes; µg: Micro gram; %: Percentage; RSD: Relative Standard Deviation