Method Development and Validation of Talquetamab by RP-HPLC in Bulk and Formulation

A simple, precise, accurate, sensitive, and specific reversed-phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of Talquetamab in pharmaceutical dosage form. Chromatographic separation was achieved on a Symmetry C18 column (150 × 4.6 mm, 5 µm) using a mobile phase consisting of 0.01 N KH?PO? buffer and acetonitrile in the ratio of 60:40 (v/v). The flow rate was maintained at 1.0 mL/min and the column temperature at 30 °C. Detection was carried out at 220 nm. The retention time of Talquetamab was 2.280 min. The method exhibited good linearity over the studied concentration range with a correlation coefficient (R²) of 0.999. The %RSD for system precision and method precision were found to be less than 1%, indicating excellent precision. The mean recovery of Talquetamab was 99.71%, confirming the accuracy of the method. The limits of detection (LOD) and quantitation (LOQ) were 0.27 µg/mL and 0.83 µg/mL, respectively. Forced degradation studies demonstrated that the method is stability- indicating. The developed method is rapid, economical, and suitable for routine quality control analysis.