Siberian Federal University

A novel, robust, and rapid reverse-phase ultra-performance liquid chromatographic (RP- UPLC) method was developed and validated for the quantification of Nicardipine Hydrochloride (NCD), a dihydropyridine calcium channel blocker. The chromatographic separation was achieved within a 2-minute runtime using a Waters Acquity UPLC system equipped with a BEH C 18 column (50 × 2.1 mm, 1.7 μm). Isocratic elution was performed with a mobile phase comprising phosphate buffer and methanol in a 20:80 (v/v) ratio, at a flow rate of 0.2 mL/min and column temperature maintained at 30 °C. Detection was carried out using a photodiode array (PDA) detector set at 237 nm, with NCD exhibiting a retention time of 1.2 minutes. The method was validated in accordance with ICH Q2(R 1) guidelines, demonstrating excellent linearity, precision, accuracy, specificity, and robustness across the validated range. Forced degradation studies under various stress conditions confirmed the method’s stability-indicating nature, with clear resolution of NCD from its degradation products. The method also demonstrated analytical sensitivity with an LOD of 0.10 μg/mL and an LOQ of 0.30 μg/mL. The proposed UPLC method is highly suitable for routine quality control analysis of Nicardipine Hydrochloride in bulk and pharmaceutical dosage forms, offering significant advantages in terms of speed, sensitivity, and reliability