RP-HPLC Method Development and Validation for The Determination of Active Ingredients in Pharmaceuticals

A rapid, accurate, and precise RP-HPLC method was developed for the simultaneous estimation of Indapamide, Amlodipine besylate, and Perindopril erbumine in a combined dosage form. The method utilized a Waters HPLC system with Empower2 software, a UV detector, and a BDS Hypersil C18 column (4.6 × 150 mm, 5 µm). The mobile phase consisted of phosphate buffer (pH 3.0) and acetonitrile (40:60) at a flow rate of 1 mL/min, with detection at 235 nm. The retention times for Indapamide, Amlodipine besylate, and Perindopril erbumine were 2.54, 3.65, and 4.14 minutes, respectively. Assay studies confirmed that the formulation contained 100.12% Indapamide, 100.32% Amlodipine besylate, and 100.42% Perindopril erbumine. System suitability parameters, including theoretical plates, tailing factor, and resolution, were within acceptable limits. The method demonstrated linearity within the concentration range of 3–18 µg/mL for Indapamide, 3–5 µg/mL for Amlodipine besylate, and 3–6 µg/mL for Perindopril erbumine. The accuracy results showed recoveries of 99.22%, 99.21%, and 99.61% for Indapamide, Amlodipine besylate, and Perindopril erbumine, respectively. Precision studies indicated %RSD values below 2%, confirming method reproducibility. Robustness and ruggedness evaluations showed minimal variability under slight changes in analytical conditions. The method was validated as per ICH guidelines and proved to be simple, precise, specific, and economical. It is suitable for routine quality control analysis of these drugs in pharmaceutical formulations.