International Journal on Science and Technology

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Advanced UHPLC-Based Analytical Framework for Concurrent Quantification of Amlodipine and Lisinopril: A Design of Experiments Optimization Strategy

Author(s) Mr. Mohamed Shajith M, Ms. Karunya B
Country India
Abstract Amlodipine and lisinopril combination treatment is frequently utilized in the management of hypertension. This research aimed to develop a novel, straightforward, rapid, precise, efficient, and reproducible UHPLC method for these medications in solid dosage forms, with validation conducted in line with ICH standards. Pharmaceutical analysis plays a pivotal role in identifying, quantifying, and characterizing pharmaceutical compounds. Chromatographic analysis was performed using the statistical software Design Expert 13. A stability indicator technique was established, developed, and fine-tuned for the simultaneous quantification of amlodipine and lisinopril. The CCD was prepared with three independent variables: wavelength (210-215 nm), flow rate (0.5-1 mL/min), and runtime (2-10 minutes). The dependent variables selected were retention time, peak area, and theoretical plate. The effective separation of AMD and LSN was achieved on Luna C18 (4.6 mm × 150 mm; 5 μm particle size), which was used to aid in accomplishing chromatographic separation using Acetonitrile: Water: Phosphoric acid (pH 2.5) adjusted by phosphoric acid at 245:740:15 % volume with a 1.0 mL/min flow rate at 215 nm. The developed method was successful in achieving good retention times and peak shapes for amlodipine (1.694 min) and lisinopril (3.365 min). The suggested approach was confirmed under the ICH Q2(R1) guidelines, showing outstanding linearity, precision, accuracy, and robustness. This comprehensive analytical approach demonstrates UHPLC's relevance for routine pharmaceutical quality control.
Keywords amlodipine, lisinopril, UHPLC, method validation, central composite design, experimental design.
Field Chemistry > Pharmacy
Published In Volume 16, Issue 3, July-September 2025
Published On 2025-08-07
DOI https://doi.org/10.71097/IJSAT.v16.i3.7627
Short DOI https://doi.org/g9wh7b
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