Abstract
The aim of this work was to develop a single, generally applicable high performance liquid chromatography/diode array detector (HPLC/DAD) method for simultaneous determination of the most frequently used cough and cold active substances and their impurities that would be applicable for a number of possible formulation compositions of cough and cold medicines. The compounds that are separated by the method include eleven active substances: paracetamol, phenylephrine HCl, caffeine, ibuprofen, ascorbic acid, propiphenazone, pheniramine maleate, chlorphenamine maleate, pseudoephedrine HCl, dextromethorphan HBr and cetylpyridinium Cl; five of their impurities: 4-aminophenol, 4-nitrophenol, 4`-chloroacetanilide, chlorphenamine impurity C and ephedrine HCl; and two preservatives: sodium benzoate and propyl parahydroxybenzoate. All 18 compounds were successfully separated on a reversed phase (RP)-HPLC column with superficially porous particles using gradient elution with a very simple mobile phase in 14 minutes with excellent sensitivity and resolution. Method optimization was performed by the design of experiments approach. The proposed method has been validated according to ICH guidelines and proved to be suitable for the simultaneous qualitative and quantitative determination of the selected compounds in different cough and cold dosage forms. Keywords: cough and cold active substances and impurities, HPLC/DAD, superficially porous particles, core-shell particles, chemometrics, design of experiments
Highlights
The cough and cold category represents a large part of over-the-counter (OTC) medicines, and encloses a vast and diverse array of pharmaceutical formulations usually containing a combination of two or more active ingredients that target multiple symptoms at once
Reliable, fast and efficient method for the most frequently encountered compounds and their impurities in multi-component cough and cold combinations that could be used for their simultaneous quantitative determination and would be applicable to different dosage forms offers a benefit in the quality control of these preparations, reducing time and cost of the analysis
Considering that the goal was to come up with a fast and simple reversed phase (RP)-HPLC method that would be useful in the everyday of the analytical laboratory, the method aimed to encompass as many of the most frequently analysed compounds in cough and cold preparations
Summary
The cough and cold category represents a large part of over-the-counter (OTC) medicines, and encloses a vast and diverse array of pharmaceutical formulations usually containing a combination of two or more active ingredients that target multiple symptoms at once. The most frequently used formulations comprise a combination of a decongestant, antihistamine, analgesic, antitussive and according to the pharmaceutical form may contain preservatives in addition to numerous excipients (Table 1) (Van Schoor, 2013). Reliable, fast and efficient method for the most frequently encountered compounds and their impurities in multi-component cough and cold combinations that could be used for their simultaneous quantitative determination and would be applicable to different dosage forms offers a benefit in the quality control of these preparations, reducing time and cost of the analysis. Its use could further be broadened to detecting these active substances in natural products for cough and cold treatment where they should not be present
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