Validation and Development of a Method for Identification and Stability Analysis of Delafloxacin Separation Using LC-MS/MS

Abstract

In order todevelop and validate the technique for delafloxacin authors are used the peak intense which is furthermore improved to this present investigation employing a variety of parameters, which includes column, alteration of eluent ratio, and rate of flow.For this development authors are usedWaters column with 2.1 mm x 100 mm, 5µm, C18. Mobile phase as 0.2% formic acid with pH of 2.6 and acetonitrile in the proportion of 30v/v:70v/v. The retention was 1.2 minutes and the rate of flow is identified as 0.12 µL/min. Forced degradation studies reveals that the peaksobtained are homogeneousand there are noco-elutingpeaks. The % RSD was found to be 3.5. Six LLOQ concentrations (10 ng/ml-1)of delafloxacin were evaluated in order to carry out the precision study.The results of calibration curve were 232.8, 0.9968, and 1273, respectivelyfor slope, coefficient of correlation (r2), and intercept.Mass spectrum development is done by the utilization of MRM ion mode (ES+) with mass transitions of m/z 441.10 > 379.10 (amu). On ionization,both parent and daughter ions were identified. 10–150 ng/mL is the calibration curve which reveals that linear by lower quantification limit of 10.00ng/ml. LOQ- 50.00ng/ml, MOQ-100.00ng/ml, HOQ -150.00ng/ml set to accuracy studies.In this present study, the research could be very helpful inlocating other potential DPs and process-related impurities that might be present indelafloxacin in very small amounts.