Method development and validation of rizatriptan in dosage form by RP - HPLC

Abstract

Rizatriptan is a drug used in the treatment of migrane. This attempt was made to develop a simple, accurate & precise method for the routine analysis of Rizatriptan. This method was developed on trial & error basis by changing the variables wherever required. Finally a method was optimized and the conditions were determined by using RP HPLC Method. The optimized method used contains 70 volumes of phosphate buffer Ph7.8 and 30 volumes of acetonitrile at 235 nm and is validated as per ICH guidelines. The method was validated for system suitability, linearity, precision, accuracy, specificity, robustness, LOD and LOQ. The system suitability parameters were within limit, hence it was concluded that the system was suitable to perform the assay. The method shows linearity between the concentration ranges of 40-70 µg / ml for Rizatriptan and R2 value was found to be 0.998. As there was no interference due to mobile phase, the method was found to be specific. The method was also found to be robust and rugged. The proposed method developed was suitable for the quantitative determination of Rizatriptan in dosageforms.