Validated RP-HPLC method for simultaneous determination and quantification of chlorpheniramine maleate, paracetamol and caffeine in tablet formulation.

Akwasi Acheampong,Wilfred Owusu Gyasi,Godfred Darko,Sylvester Addai-Arhin,Joseph Apau

doi:10.1186/s40064-016-2241-2

Abstract

Chlorpheniramine maleate–paracetamol–caffeine tablet formulation is one of the common over-the-counter drugs used for the treatment of cold and cough. A reversed-phase high-performance liquid-chromatography method has been successfully developed for the simultaneous determination of chlorpheniramine maleate, paracetamol and caffeine in a drug formulation. The RP-HPLC method employed a Phenomenex C18 reversed phase column (Luna 5µ, 250 × 4.6 mm) with an isocratic mixture of methanol and 0.05 M dibasic phosphate buffer pH 4.0 in the ratio of (30:70; v/v) as the mobile phase. The column temperature was kept at 30 °C. The flow rate was 1.0 mL/min and detection was by means of a UV detector at wavelength of 215 nm. All the active components were successfully eluted with mean retention times of 2.4, 4.2, 7.2 min for chlorpheniramine maleate, paracetamol and caffeine respectively. The method was found to be linear (R2 > 0.99), precise (RSD < 2.0 %), accurate (recoveries 97.9–102.8 %), specific, simple, sensitive, rapid and robust. The validated method can be used in routine quality control analysis of fixed dose combination tablets containing chlorpheniramine maleate, paracetamol and caffeine without any interference by excipients.

Highlights

Drug combinations are single preparations containing two or more active pharmaceutical ingredients (APIs) for the purpose of their concurrent administration as a fixed dose mixture combinations drug
Most multicomponent drug formulations usually contain two or more active ingredients which are responsible for a combined therapeutic activity of the drug
Monographs in most official pharmacopoeia are for single component drugs, local Pharmaceutical manufacturing companies in the analysis of multicomponent drug formulations use methods that involve multiple and repeated extractions to extract each active component before their quantification using spectrophotometry or titrimetry

Summary

Introduction

Drug combinations are single preparations containing two or more active pharmaceutical ingredients (APIs) for the purpose of their concurrent administration as a fixed dose mixture combinations drug. Most multicomponent drug formulations usually contain two or more active ingredients which are responsible for a combined therapeutic activity of the drug. Monographs in most official pharmacopoeia are for single component drugs, local Pharmaceutical manufacturing companies in the analysis of multicomponent drug formulations use methods that involve multiple and repeated extractions to extract each active component before their quantification using spectrophotometry or titrimetry. This has led to researchers developing various methods to help facilitate easy and quick analysis

Methods

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Conclusion