A Spectrophotometric Method for the Determination of Ramipril in Solid Dosage Forms
Purpose: To develop a simple and cost effective spectrophotometer method for the determination of ACE inhibitor ramipril in dosage forms.
Methods: UV spectrophotometry was used to develop and validate a simple method for the assay of ramipril in solid dosage form at λmax of 210 nm, as per International Conference on Harmonization (ICH) guidelines. Aqueous methanol (5 %) was used as the blank solvent. The method was validated for linearity, recovery, accuracy, precision, specificity in the presence of excipients, and also for inter-day stability under laboratory conditions.
Results: Validation results showed linearity in the range 1 – 38 μg/ml; recovery accuracy 101.55%; regression equation Y = 0.0256X + 0.0697, R² of 0.9942; precision RSD < 2.00 %; and negligible interference from common excipients and colorants. The method was accurate (95 % confidence limit) compared to standard liquid chromatography (LC) method, with comparable reproducibility when used to assay a commercial product (Ramitace®, 2 and 5 mg tablets).
Conclusion: The validated data were within allowable limits and therefore, the proposed method is recommended for routine quality control (QC) analysis
Keywords: Ramipril, Spectrophotmetric assay, Validation, Solid dosage forms