Chromatographic Assurance: Validating Analytical Methods for Novel N-(4-Bromophenyl)-2-Phenyl-6,7-Dihydro-5hCyclopenta[D]Pyrimidin-4-Amine Using Rp-HPLC by a Qbd Approach

Abstract

Introduction: A novel, fast, economical, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) technique was developed for determining N-(4-bromophenyl)-2-phenyl-6,7-dihydro-5H-cyclopenta[d]pyrimidin-4-amine in bulk drug substance.

Objectives: The study was to design to develop a chromatographic method for the estimation of N-(4-bromophenyl)-2-phenyl-6,7-dihydro-5H-cyclopenta[d]pyrimidin-4-amine which is simple, precise, accurate, and cost-effective N-(4-bromophenyl)-2-phenyl-6,7-dihydro-5H-cyclopenta[d]pyrimidin-4-amine by RP-HPLC and validate as per ICH guideline. (ICH Q2 (R1)

Methods: During the experiment, the method was found trustworthy in eluting drugs using an isocratic approach on a C18 column (4.6 mm x 250 mm, 5.0 μm) at room temperature, employing a mobile phase composed of methanol and water in a ratio of 80:20, flowing at 1 mL/min, with U.V. detection set at 249 nm.

Results: The developed method was validated and displayed linear behavior within a concentration range of 10-50 µg/mL (r2=0.999), with a detection limit of 0.017 µg/ml. Method accuracy ranged from 99.95% to 100.37%. Intra-day and inter-day precision fell within the range of 0.13-0.96 % to 0.11-0.63 %, respectively. This validated method, demonstrating exceptional selectivity, Linearity, sensitivity, Precision, and accuracy, is suitable for quantifying the model drug in both bulk drug substances and pharmaceutical formulations.

Conclusions: The method was found to be reliable and robust, which was confirmed through QbD analysis. No experiments have been performed and documented to till date for N-(4-bromophenyl)-2-phenyl-6,7-dihydro-5H-cyclopenta[d]pyrimidin-4-amine by HPLC.