Analytical method validation for assay of propiverine HClmodified release pellets drug product

Propiverine HCl is a drug active substance used in the treatment of overactive bladder syndrome, which has increased in recent years, and can be used as a modified release drug product. This study focuses on assay of the drug product containing Propiverine HCl modified release pellets by using high pressure liquid chromatography. It was aimed to reduce solvent consumption and energy saving with using ultra-performance liquid chromatography technology. Within the scope of this thesis, an appropriate analytical method was developed, optimized by targeting energy, time and consumables consumption and validated in accordance with ICH guidelines.