Simultaneous Determination Of Two APIs And Their Related Compounds By HPLC On An Alliance™ iS HPLC System

Analyzing the contents of medications with active pharmaceutical ingredients (APIs), for quality assurance and quality control purposes, is essential to ensure compliance with regulatory requirements for pharmaceutical composition, dosage, and purity.

In recent years, the United States Pharmacopeia (USP) has undertaken a modernization effort to update outdated analytical methodologies in its monographs. A key element of the modernization process is the elimination of hazardous solvents and reagents in the analytical procedure.

The industry currently uses separate chromatographic methods to analyze each API in pharmaceutical formulations, which can generate large amounts of hazardous waste from organic solvents. One solution to minimize hazardous waste is to use a single chromatographic method for the analysis of multiple active materials.

In this study, three USP chromatographic methods are combined into a single liquid chromatographic method to analyze two APIs, naphazoline hydrochloride and pheniramine maleate, and their related compounds. As a practical application, the method was successfully used for the routine analysis of commercially available ophthalmic and nasal solutions, without significant interference from the excipients.