1Clinical Pharmacy Department, Al-Rayan National College of Health Sciences, Al-Rayan National Colleges, P.O. Box 167 Al Madinah Al Munawwara 41411, Saudi Arabia. Email: anjumibrahem@gmail.com, am.muhammad@amc.edu.sa
Background: The present study focuses on the development and validation of a simple, sensitive, and cost-effective reverse-phase high-performance liquid chromatography (RP-HPLC) method for quantitative analysis of Amlodipine besylate in the oral pharmaceutical tablet formulation.
Methods: Chromatographic analysis was performed using a C18 column with a mobile phase consisting of acetonitrile:water (60:40 v/v), adjusted to pH 3.0 with orthophosphoric acid, at a flow rate of 1.2 mL/min and detection wavelength of 237 nm. Amlodipine besylate showed a retention time of 5.0 ± 0.1 min. The analytical method was validated as per ICH guidelines and demonstrated excellent linearity (r² = 0.999) over the concentration range of 2–50 µg/mL. The accuracy ranged from 98.3–101.2%, while intra- and inter-day precision showed relative standard deviation values below 2.0%. The limit of detection and limit of quantification were found to be 0.25 µg/mL and 0.75 µg/mL, respectively.
Conclusion: The validated HPLC method was successfully applied for drug content estimation, providing a robust, economical, and reproducible approach for formulation development and routine quality control of amlodipine besylate in pharmaceutical dosage forms.
Keywords: Amlodipine besylate; HPLC; purity determination; method validation; pharmaceutical analysis
How to cite this article: Ibrahem AMM. Development and Validation of Simple and Cost-Effective HPLC Method for Determination of Purity of Amlodipine Besylate (API) in the Pharmaceutical Formulation. Int J Drug Deliv Technol. 2026;16(13s): 616-621. DOI: 10.25258/ijddt.16.13s.68
Source of support: Nil.
Conflict of interest: None