Development And Validation of Rp-HPLC Method by Using Amlodipine Besylate

A rapid, precise, and accurate Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of the anti-hypertensive drug Amlodipine. The method was optimized using a suitable mobile phase, column, flow rate, and detection wavelength to ensure effective separation and quantification. Various analytical parameters, including system suitability, linearity, accuracy, precision, robustness, and limit of detection (LOD) & limit of quantification (LOQ), were evaluated as per ICH guidelines. The method demonstrated excellent linearity over the specified concentration range, with high precision and accuracy. Robustness studies confirmed the method’s reliability under small variations in chromatographic conditions. The developed RP-HPLC method was successfully applied for the routine analysis of Amlodipine in bulk and pharmaceutical dosage forms.