Analytical Quality by Design Based Robust RP-HPLC Method for Estimation of Setracanozole in Bulk and Tablet Formulation-Method Development and Validation

The key aim of the stated research was to develop and validate robust, sensitive, simple RP-HPLC with enhanced performance for estimating Setracanozole in API powder and tablet formulation by implementing analytical quality by-design studies. The method was optimized by the central composite design of the response surface study. Successful separation of Setracanozole was obtained using C18 (250 x 4.6mm, 5μ column and a mobile phase of methanol: 0.1% v/v formic acid (90:10) with 1.0ml/min flow rate. The separated Setracanozole and its degradants were explored with a UV detector at 245nm. The RT of Setracanozole was observed to be 4.2min. The approach was validated per ICH, proving it was more sensitive, precise, accurate, and specific. The lowest concentration of Setracanozole’s limit of detection and quantification makes guarantees regarding the method’s sensitivity. For the provided range of linear concentrations (2.5 to 30μg/ml), the regression coefficient was found to be 0.999. The computed average percentage recoveries of Setracanozole in spiked solutions ranged from 99.1 to 101.75%. The % degradation of Setracanozole in various forced conditions confirmed the existing method’s stability. Setracanozole was significantly sensitive to base hydrolysis when compared to other stressful conditions such as Acid hydrolysis, thermal degradation, and photodegradation. The proposed HPLC approach separated Setracanozole with high sensitivity, a short retention time, and an affordable solvent system. As a result, the proposed method can be used in the pharmaceutical industry.