A Simple Stability-Indicating UPLC Method for quantification of Tirzepatide in Bulk drug and Pharmaceutical Formulations

Abstract

Analytical method development and validation are the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It helps in establishment of product-specific acceptance criteria and stability of results. In view of this the present work is intended to develop an efficient and simple UPLC method for the determination of Tirzepatide in bulk and was applied on marketed Tirzepatide products. The method was linear at the concentration range of 5–17.5 μg/ml for Tirzepatide. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. LOD and LOQ were found to be 0.01 µg/mL and 0.102 µg/mL for Tirzepatide. Results confirmed that the method was sensitive and can be useful for the detection and analysis of drugs at very lowest concentrations. The method can effectively separate the forced degradation products formed during the stress study confirms the stability indicating nature of the method. Hence it the method reported in the present study was used for the separation and quantification of Tirzepatide in bulk drug, formulations as well as stability testing.