Method Development And Validation For Estimation Of Berotralstat By Using Lc-Ms/Ms Method

Abstract

A mixture of acetonitrile, Milli-Q water, and formic acid was prepared in a ratio of 70:30:0.1%, respectively. The mixture was then subjected to sonication in order to remove any dissolved gases. The approach was successfully tested within a linear concentration range spanning from 30 to 1000 ng/mL, exhibiting a high correlation coefficient (R2) value of 0.999. The percentage relative standard deviation (%RSD) of the peak response obtained from five replicate injections of standard concentration was determined to be less than 2, suggesting that the suggested approach exhibits a high level of precision. The observed percentage recoveries of the active pharmaceutical ingredient (API) from the dosage forms of Berotralstat exhibited a range of 97.81% to 103.33% w/w. These results suggest that the suggested approach is deemed accurate. The limit of detection (LOD) and limit of quantification (LOQ) values for Berotralstat were determined to be 0.5 ng/mL and 1 ng/mL, respectively. These values demonstrate the method's sensitivity. Therefore, the analysis of pharmaceutical formulations demonstrates that the proposed method is highly suitable for their examination, as it exhibits minimal interference from the typical additives commonly found in such formulations. The LC-MS approach presented in this study demonstrates simplicity, sensitivity, and reliability. It is suitable for the regular analysis of Berotralstat in both bulk samples and pharmaceutical formulations, depending on the unique requirements of the situation at hand.