Method Development Validation and Degradation studies of Voriconazole Drug by RP-HPLC Method

Eswara Rao Bammidi*¹, Vaikuntarao Lakinani¹, Rathnakar Reddy Kura^2 
1Departmernt of Chemistry, GITAM Institute of Science, GITAM University, Visakhapatnam, A.P., India
²Hetero Research Foundation, Hetero Drugs Ltd, Hyderabad, India

Abstract
A rapid and sensitive RP–HPLC method with UV detection (260 nm) for routine analysis of voriconazole was developed. Chromatography was performed with mobile phase containing a mixture of acetonitrile and water (50:50, v/v) with flow rate of 1.0 ml min−1. Quantitation was accomplished with internal standard method. The procedure was validated for linearity (correlation coefficient = 0.9999), accuracy, robustness and intermediate precision. Experimental design was used for validation of robustness and intermediate precision. To test robustness, three factors were considered namely Percentage of acetonitrile in mobile phase, Flow rate and pH. An increase in the flow rate results in decrease of the drug found concentration, while the percentage of organic modifier and pH has no important effect on the response. For intermediate precision measure the variables considered were: analyst, equipment and number of days. The R.S.D. value (0.45%, n = 24) indicated a good precision of the analytical method. The proposed method was simple, highly sensitive, precise and accurate and retention time less than 4 min indicating that the method is useful for routine quality control.
Keywords: Voriconazole, HPLC, Degradation studies