Efficient RP-HPLC Method Development for Analysis and accurate Quantification of Specific Anti-Hypertensive Agents in Pharmaceutical Dosage Forms
DOI:
https://doi.org/10.9734/bpi/acpr/v6/2974GKeywords:
Atenolol, metaprolol, hydrochlorothiazide, amlodipine, RP-HPLC, ICH guidelines, simultaneous quantificationAbstract
This research paper presents the development and validation of a rapid, precise, and economical reversed-phase liquid chromatographic method for simultaneous quantification of four anti-hypertensive agents (ATN, MET, HZT, and AML) and a validated analytical method for the combination of ATN with AML in tablet dosage form. The method, based on a C18 column with optimized conditions, demonstrated well-resolved peaks, good symmetry, and minimal tailing. Validation according to ICH guidelines confirmed specificity, linearity, precision, accuracy, and robustness, with LOD and LOQ values indicating high sensitivity. The proposed method was successfully applied to quantify drug levels in a commercial formulation, with mean assay values within acceptable limits. The study addresses the inadequacies of existing methods, providing a valuable contribution to analytical techniques for anti-hypertensive drug analysis.