RP-HPLC Method Development and Validation of a Stability Indicating Cidofovir in Its Pure and Dosage Form

Abstract

High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of Cidofovir was done by waters HPLC with auto sampler and PDA detector. The buffer 1ml TFA in 1000ml water. Adjust this solution to pH 3 by using acid / base based on the PH of the resulted solution and Mix a mixture of above ACN 650ml (65%), 350 ml TFA (35%) and degas in ultrasonic water bath for 5 minutes. Filter through 0.45 µ filter under vacuum filtration. Inspire (150X4.6mm 5µm) or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using UV detector at 230nm. The solutions were chromatographed at a constant flow rate of 1ml/min and Injection volume 20l, the run time 10min, the linearity range was found to lie from 20µg/ml to 50µg/ml of Cidofovir. The results obtained on the validation parameters met ICH and USP requirements. It inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis.