QbD Approach for Analysis of Tirzepatide in its Bulk and Marketed Formulation by Stability Indicating RP-HPLC

Abstract

The core intentions of the stated work has been to create and validate a simple, sensitive, specific, precise and cost-effective RP-HPLC method with good performance for the investigation of tirzepatide in API powder and its marketed formulation. HPLC system (WATERS) equipped with DAD detection system was used to develop the current system. The procedure conditions of BDS C18 (150 x 4.6 mm,5 m), 0.01N KH2PO4: Acetonitrile in the ratio of 41:59 (% v/v), a flow of 0.9 mL/min, and a temperature of 31°C were successfully optimized by central composite design of QbD experiments. The optimized wavelength selected was 250 nm. RT of tirzepatide was observed to be 2.841 minutes with good system suitability. The ICH Q2(R1) standards functioned as a validation for the planned action strategy. Linearity was observed for 5 to 30 μg/mL concentration series of tirzepatide with R2 of 0.999. The %RSD results of both precisions were found in the range of 0.40 to 0.41.% recovery of Tirzepatide in spiked samples was assessed to be 99.89%. The LoD and LoQ of tirzepatide were calculated to be 0.05 and 0.14 μg/mL, respectively. The results assured that the established procedure was simple, sensitive, specific, accurate and cost- effective. Exploration of tirzepatide under a diversity of FD conditions represents the stability representing the quality of the established HPLC procedure. Hence, the anticipated process has significant credit in the pharmaceutical segment.