QbD-driven RP-HPLC method for the simultaneous analysis of dihydropyridines calcium channel blockers in pharmaceuticals.

ABSTRACT: A rapid, sensitive, and selective reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous determination of five dihydropyridines calcium channel blockers, namely: amlodipine (AML), nifedipine (NIF), lercanidipine (LER), nimodipine (NIM) and nitrendipine (NIT) using Quality by Design approaches (QbD). The chromatographic separation was achieved on Luna C8 (100 × 4.6 mm 3 μm) column using an isocratic mobile phase consisting of acetonitrile-methanol - 0.7% triethylamine pH 3.06 (30-35-35) adjusted with ortho phosphoric acid at a flow rate of 1 mL/min with UV detection at 237 nm. The optimized method demonstrated good chromatographic resolution with average retention times of 2.93, 3.98, 4.98, 6.32 and 7.75 min for AML, NIF, LER

SUBMITTER: Horyn M 

PROVIDER: S-EPMC12574138 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature