Development of a Stability Indicating UPLC Method for the Determination of Tirbanibulin in Bulk and its Pharmaceutical Dosage Form

INTRODUCTION: The primary goal of this study was to create and validate a simple, precise, sensitive, and accurate UPLC method for estimating tirbanibulin in pure and dosage form.

METHODS: The UPLC technique was developed using a Waters Acquity UPLC Phenyl (100x2.1mm,1.7m) column. The developed technique was validated in accordance with the International Conference on Harmonization's (ICH) guidelines.
RESULTS: Tirbanibulin was separated chromatographically with high resolutions using the mobile phase acetonitrile: buffer (30: 70 v/v) at 0.5 mL/min, 5 µL injection volume, and 220 nm wavelength. The validated technique was found to be linear in the 1—15 µg/mL range. The detection and quantification limits for tirbanibulin were determined to be 0.03 and 0.1µ g/mL, respectively. The percentage RSD was less than 2%, demonstrating the precision of the developed technique. Furthermore, the recovery rate was nearly 100%, confirming the method's accuracy. Minor modifications to the chromatographic conditions demonstrated the method's robustness.
DISCUSSION AND CONCLUSION: The developed analytical method was precise, simple, reproducible, and sensitive. As a result, it can be used to determine tirbanibulin.