SIMULTANEOUS ESTIMATION OF AMLODIPINE AND TELMISARTAN INCLUDING METHOD DEVELOPMENT AND METHOD VALIDATION BY RP-HPLC IN SOLID DOSAGE FORM

Validation entails a systematic approach to ensure that processes, systems, procedures, and equipment consistently execute their intended functions and provide dependable outcomes. Validation is critical for ensuring quality, adhering to regulatory standards, and reducing production and operational risks. The developed method was novel and simple for the simultaneous estimation of Amlodipine & Telmisartan by RP-HPLC. The two peaks were well resolved at 254nm in isocratic mode at retention times 7.625 and 11.531 min for Amlodipine and Telmisartan respectively at a run time of 20 min and flow rate 1.0 ml/min with 250mm x 4.6mm, 5µm column & Ammonium acetate buffer: methanol (20:80) as mobile phase. % Assay values for Amlodipine and Telmisartan were found to be 98.59% & 99.17% respectively. Linearity was obtained in the range of 16-48 ppm & 20-60 ppm and linearity correlation coefficient was found to be 0.9925 & 0.9955 for Amlodipine and Telmisartan respectively. This new approach was verified using ICH guidelines and found to be specific, sensitive, precise, accurate, and linear.