Tropical Journal of Pharmaceutical Research

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Research Article

A Spectrophotometric Method for the Determination of Ramipril in Solid Dosage Forms

OE Afieroho¹*, O Okorie²and TJN Okonkwo³

¹Department of Medicinal Chemistry and Quality Control, National Institute for Pharmaceutical Research and Development, Abuja, ²Pharmaceutics & Pharmaceutical Technology Department, ³Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmaceutical Sciences, University of Port Harcourt, East-West Rd, Choba, Port Harcourt, Nigeria.

*For correspondence: Email: eriarieafieroho@yahoo.com

Received: 17 December 2010 Revised accepted: 31 January 2012

Tropical Journal of Pharmaceutical Research, April 2012; 11(2): 275-279

http://dx.doi.org/10.4314/tjpr.v11i2.15

Abstract

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 λ_max 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