Forced Degradation and Stability Indicating Method Development and Validation of Ratinovir by RP-HPLC In Bulk and Pharmaceutical Dosage Form

Abstract

A stable, simple, accurate, precise, robust and highly selective Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method was developed and validated using ritonavir.Chromatographic separation was achieved using cyber labs, LC 100 separation module, Agilent C18 column at temperature 30°C. Flow rate selected was 1ml/min. Both drugs are identified with UV detector at 256nm. Mobile phase employed was Methanol: Water (50:50), which resulted best sensitivity. Developed method was validated in terms of linearity, range (25-150µg/ml), precession (correlation coefficient is less than 0.999), robustness, accuracy(recovery was 101.96%) and under stress conditions drug degradation was less than 10%.The validation of proposed stability indicating method was verified by recovery studies and can be applicable in routine pharmaceutical analysis.