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

Research Article

Austin J Anal Pharm Chem. 2017; 4(2): 1087.

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

Siddareddy K¹*, Aswartha Umakantareddy M¹ and Sreeramulu J²

¹Department of Chemistry, Rayalaseema University, Andhra Pradesh, India

²Department of Chemistry, Sri Krishnadevaraya University, Andhra Pradesh, India

*Corresponding author: Konda SR, Department of Chemistry, Rayalaseema University, Kurnool-518002, Andhra Pradesh, India

Received: June 22, 2017; Accepted: July 18, 2017; Published: July 25, 2017

Abstract

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.

Keywords: UPLC; Lorazepam; Lorazepam related compounds; Active Pharmaceutical Ingredient; ICH guidelines

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

Introduction

Lorazepam (LP) chemically named as 7-chloro-5-(2- chlorophenyl)-3-hydroxy-1,3-dihydro-1,4-benzodiazepin-2-one [5], is used for short-term treatment of anxiety, insomnia, acute seizures including status epilepticus and sedation of hospitalized patients, as well as sedation of aggressiveness patients [1-4]. It is white or almost white, crystalline powder, practically insoluble in water, sparingly soluble in ethanol (96%), sparingly soluble or slightly soluble in methylene chloride. The molecular formula is C15H10Cl2N2O2 and the molecular weight is 321.2g/mol. It contains five specified related impurities. The chemical structure of Lorazepam and its related impurities were shown Figure 1.