METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF AMLODIPINE USING FOLIN-CIOCALTEU REAGENT BY UV-SPECTROSCOPY

Dr. B. Satya Prasad, Dr. J. N. Suresh Kumar, B. Purnima*, B. Pavani, A. Keerthi, B. Kavya, CH. Blessy Shalem Raj

ABSTRACT

A simple, accurate, precise, and cost-effective UV-Visible spectrophotometric method was developed, validated for the determination of Amlodipine Besylate in pharmaceutical formulations using Folin–Ciocalteu (FC) reagent in accordance with ICH Q2(R1) guidelines. The method is based on the formation of a blue-colored chromogen resulting from the redox reaction between Amlodipine and FC reagent in alkaline medium, with maximum absorbance measured at 760 nm. Standard solutions were prepared in the concentration range of 2–20 μg/mL, exhibiting excellent linearity with a regression coefficient (R²) of 0.9995. Accuracy of the method was evaluated by recovery studies at 80%, 100%, and 120% levels, with mean recoveries ranging from 99%, 103% and 104% indicating high reliability. Precision studies demonstrated low %RSD values of less than 1% for both intra-day and inter-day analysis, confirming good repeatability and intermediate precision. The method showed good specificity with no interference from common tablet excipients. Robustness testing revealed that small deliberate variations in experimental parameters did not significantly affect the results. The validated method was successfully applied to the assay of Amlodipine Besylate in tablet dosage forms, yielding results within acceptable limits. Therefore, the proposed method can be effectively employed for routine quality control analysis of Amlodipine Besylate in bulk and pharmaceutical formulations.

Keywords: Amlodipine Besylate, UV- Spectroscopy, Folin- Ciocalteau reagent, Method development, validation, ICH Q2 (R1) guidelines.