Published Paper Details:

A rapid, sensitive, robust, rugged and linear HPLC method is developed using QbD approach and validated as per ICH for the estimation of amlodipine impurities in tablet dosage form. Different concentration of mobile phase was used to get the satisfactory results, The mobile phase Buffer: Methanol: ACN (30:35:35) at pH to 4 is used as the mobile phase and 3? particle size C18 column of 150 mm length and 4.6 mm internal diameter is used and it gives the extremely satisfactory results. Using photo diode array (PDA) detector, the compounds are monitored at 340 nm. The Design of Experiment Central Composite designs by Design expert 8 Software was used. HPLC methods were validated as linearity, precision, accuracy, specificity, system suitability, and robustness exceeded the limit. When compared to the previously reported method, the HPLC method is more sensitive, accurate, and precise. There was no excipient interference in the recovery study. The low percent RSD and molar extinction coefficient (L mol-1 cm-1) values indicated that the developed methods were sensitive. The proposed high-performance liquid chromatographic method was also evaluated for accuracy, precision, and robustness, and it was found to be convenient and effective for Amlodipine quality control. The developed method was found to be simple and cost effective for the quail. Furthermore, the reduced solvent consumption results in a more cost-effective and environmentally friendly spectroscopic procedure. As a result, the proposed methodology is quick and selective, requires only a simple sample preparation procedure, and is suitable for Amlodipine.