• manmohan singh thakur
• kushagra barkade
• md nayyar shad
• manish upadhayay
• Dr. Udit narain soni

This study aimed to develop and validate accurate, specific, precise, and reliable analytical methods for the simultaneous quantitative estimation of Amlodipine Besylate and Atenolol in bulk drug and fixed-dose combination tablet formulations. Two distinct methods were developed: Second Derivative UV-Visible Spectrophotometry and Reverse Phase High-Performance Liquid Chromatography (RP-HPLC). For the UV method, optimization focused on resolving spectral overlap through the use of the second derivative technique, identifying zero-crossing points at 251 nm for Atenolol and 264 nm for Amlodipine in methanol as the solvent. The RP-HPLC method involved optimizing chromatographic conditions, including the mobile phase composition (Methanol:Acetonitrile:Ammonium Acetate Buffer with Sodium Pentanesulfonate, pH 3.0), a C18 stationary phase, flow rate (1.0 mL/min), and detection wavelength (230 nm), to achieve efficient separation and good peak characteristics. Both developed methods were subjected to comprehensive validation according to the International Council for Harmonisation (ICH) Q2(R1) guidelines. Validation parameters evaluated included specificity, linearity, range, accuracy, precision (repeatability and intermediate precision), limit of detection (LOD), limit of quantification (LOQ), and robustness. The validated methods were subsequently applied for the quantitative analysis of Amlodipine Besylate and Atenolol in a commercially available marketed tablet formulation to demonstrate their practical applicability for routine quality control.

Amlodipine Besylate, Atenolol, Simultaneous estimation, RP-HPLC, UV-Vis Spectrophotometry, Method validation, ICH Q2(R1), Fixed-dose combination.

"Method development and validation for simultaneous estimation of selected CVS drugs in bulk drug and marketed Dosage forms", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 5, page no.c850-c865, May-2025, Available :http://www.jetir.org/papers/JETIR2505317.pdf

"Method development and validation for simultaneous estimation of selected CVS drugs in bulk drug and marketed Dosage forms", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 5, page no. ppc850-c865, May-2025, Available at : http://www.jetir.org/papers/JETIR2505317.pdf