Validation of HPLC Method Used For the Estimation of Degradation Products of Oxazepam

Abstract

A HPLC method was validated which shows good separation for Oxazepam, its impurities and
degradation products The drug substance, its impurities and degradation products were found well
separated with gradient conditions having run time of 60 mins by using Zorbax Extended C-18 column
from Agilent (250 x 4.6 mm, 5µ). The flow rate was kept 1.0 mL.min-1. The gradient mobile phase
consisted of A= 0.02M di-potassium hydrogen phosphate pH 10.5 and B= Acetonitrile (100%).
Detection was performed at 235 nm using PDA detector. The method was validated for Specificity,
LOD, LOQ, Linearity, Precision and Accuracy as per ICH guidelines [1, 2]. The stability indicating
capability of the method was established by performing forced degradation study. The method was
found to be reliable for its intended purpose.