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

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.