Azelnidipine is an innovative dihydropyridine calcium channel blocker primarily employed in the management of hypertension. This study seeks to establish the high-performance liquid chromatography (HPLC) method for the analysis of Azelnidipine utilizing the Quality by Design (QbD) framework. It elucidates how QbD concepts were applied to design a precise and efficient HPLC process for Azelnidipine, ensuring consistent quality within established parameters. Central composite design was used to systematically investigate the effects of flow rate and mobile phase composition on HPLC. Chromatographic conditions were optimized using Design of Experiments(DOE), with Phenomenex ODS C18 column (250 mm × 4.6 mm, 5.0 µm) and mobile phase of methanol and 0.1% orthophosphoric acid (80:20, v/v). Peaks were detected at 255 nm, 0.9 ml/min flow, and 10 μl injection, eluted at 2.799 min. Linearity (r² = 0.9997) was observed over the 2–10 µg/ml range. System suitability parameters, including the tailing factor (1.18) and theoretical plates (3608). The Azelnidipine assay result was 100.87% of the labeled claim. Accuracy, precision, robustness, LOD/LOQ ensured method consistency and reliability. Degradation products produced during stress trials did not interfere with the detection. Method validation parameters met ICH-recommended ranges. The proposed method is speedy, accurate, precise, and cost-effective, making it well-suited for pharmaceutical analysis of Azelnidipine.
Gavali et al. (Tue,) studied this question.
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