Development and Validation of HPLC Method for Simultaneous Estimation of Brimonidine Tartrate and Timolol Maleate in Bulk and Pharmaceutical Dosage Form

Abdullah A Elshanawane

doi:10.4172/2157-7064.1000230

Abstract

Brimonidine tartrate and Timolol Maleate are used in treatment of glaucoma by decreasing intra ocular pressure. A validated HPLC method was developed for the assay of them. The method was performed on BDS HYPERSIL Cyano column (250×4.6 mm, 5 μ) and the mobile phase consisted of Ammonium acetate (pH 5.0, 0.01 M) - Methanol (40:60, V/V) which pumped at a flow rate equals to 1.5 ml/min at ambient temperature. 20 μl of drugs sample solutions were monitored at two fixed wavelengths (lambda=254.0 nm for Brimonidine Tartrate and 300.0 nm for Timolol Maleate). The proposed method was validated in terms of linearity, accuracy, precision and limits of detection and quantitation according to ICH.

Highlights

Glaucoma describes a group of disorders characterized by a loss of visual field associated with cupping of the optic disc and optic nerve damage
Two methods were only reported for estimation of this combination, the first is HPTLC [32] and the other is High Performance Liquid Chromatography (HPLC) method [33]
Development of HPLC method for simultaneous estimation of this combination is a must and our scope that our new method will fulfill all requirements of validation according to ICH guidelines

Summary

Introduction

Glaucoma describes a group of disorders characterized by a loss of visual field associated with cupping of the optic disc and optic nerve damage. Two methods were only reported for estimation of this combination, the first is HPTLC [32] and the other is HPLC method [33] The latter does not fulfill all requirements of validation which will be discussed later. Development of HPLC method for simultaneous estimation of this combination is a must and our scope that our new method will fulfill all requirements of validation according to ICH guidelines. It should be characterized by simplicity, fast analysis, sensitivity and suitability for routine pharmaceutical analysis

Materials and Methods

Method validation

Results and Discussion

Proposed methods