DEVELOPMENT AND VALIDATION OF A NEW HPLC METHOD FOR THE DETECTION OF SONIDEGIB IN MOBILE PHASE AND HUMAN PLASMA

The main aim of the present research work is to develop a sensitive, precise and accurate HPLC (High-Performance Liquid Chromatography) procedure for the selective estimation of sonidegib in both human plasma and mobile phase. An isocratic separation of sonidegib through a 5µ Zorbax C-18 analytical column with the dimensions of 25 cm × 4.6 mm utilizing mobile phase composition of methanol, water and acetonitrile at a ratio of 10:10:80 v/v. The detection of the analyte was processed at the maximum wavelength of 254 nm and with 1 ml/min flow of the mobile phase. The drug was eluted from the column at the retention time of 3.6 min in plasma samples and 4.81 min in movable phase. Five variable concentration levels of 5, 10, 15, 20, and 25 μg/ml were used for the estimation of recovery and linearity. The recovery findings were 5.03, 9.93, 14.96, 20.14, and 24.91 μg/ml, respectively, for Sonidegib in the mobile phase. Similarly, 6 concentration levels of 20, 40, 200, 400, 800, and 1200 μg/ml were utilized for recovery study, and the findings were 20.15, 40.21, 199.62, 398.16, 798.81 and 1197.28 μg/ml respectively for Sonidegib in plasma. The % RSD findings were found to be <2%, and the correlation coefficient was more than 0.999. The developed method can be useful in bioavailability and bioequivalence studies.