Pioneering RP-HPLC strategy for synchronous evaluation of assay and dissolution testing of piracetam and vincamine: A promising combination for cognitive and cerebrovascular disorders

Abstract Cognitive and cerebrovascular disorders, such as dementia, Alzheimer's disease, and ischemic stroke, present significant global health challenges, particularly in aging populations. These conditions are characterized by cognitive decline and reduced cerebral blood flow, necessitating therapeutic strategies that address both aspects. Piracetam (PCM), a nootropic agent, enhances memory, learning, and neuroprotection. Vincamine (VCM), a cerebral vasodilator, improves blood flow and oxygen utilization. Their combination offers a synergistic approach to managing dementia impairment with vascular insufficiency. We evaluated RP-HPLC using AGREEprep and ComplexGAPI. PCM and VCM were measured concurrently in pharmaceutical formulations using RP-HPLC to ensure quality, safety, and efficacy. The process offered excellent linearity over a concentration range of 3–50 μg mL −1 for each drug, with coefficients of determination ( R 2 ) of 0.999. High sensitivity was achieved, with limits of detection (LOD) of 0.93 μg mL −1 for VCM and 0.32 μg mL −1 for PCM, and limits of quantitation (LOQ) of 2.81 μg mL −1 and 0.90 μg mL −1 . Accuracy studies revealed recoveries close to 100% for both drugs, with intra-day and inter-day precision showing RSD ≤2. System suitability parameters met pharmacopeial standards. Dissolution testing in media at pH 1.2, 4.5, and 6.8 revealed pH-dependent release of VCM, with 95.10% dissolution at pH 1.2 and 72% at pH 6.8 after 60 min. In contrast, PCM exhibited rapid and complete dissolution (>95% within 5 min) across all pH levels, consistent with its high solubility. These results validate the method as reliable for quality control and dissolution testing. This supports the development of this promising combination for cognitive and cerebrovascular disorders.