Quantification of Tablets Containing Multiple APIs: Using Transmission Raman

The ability to predict multiple constituents of a final dosage form in one fast, non-destructive measurement can reduce analysis time. This is especially important when quantification of multiple APIs is required for tests such as content uniformity, assay and ID…

Abstract

The ability to predict multiple constituents of a final dosage form in one fast, non-destructive measurement can reduce analysis time. This is especially important when quantification of multiple APIs is required for tests such as content uniformity, assay and ID.

This example, based on a common cold and flu product, demonstrates the quantification of 5 components (3 APIs and 2 excipients) using a 9 second measurement. Nominal concentration ranged from 1 to 85 % w/w.

Introduction

Typical solid dose forms of a drug product are often complex and contain at least one active pharmaceutical ingredient (API) and a range of excipients at varying levels. The most widely-used means of quantitative analysis is high performance liquid chromatography (HPLC), which is slow, laborious, prone to manual errors and expensive. Transmission Raman spectroscopy (TRS) is a regulatory-acceptable alternative technique for content uniformity, assay and drug product ID, enabling fast, non-destructive analysis of tablets and capsules without chemical preparation or skilled analytical chemists.

Usually only APIs are quantified, but monitoring excipients as well as API’s may be advantageous. For example, if a particular batch of drug product differs in terms of one of its excipients, it may affect one of the quality critical attributes such as dissolution. This extra information comes with almost no extra cost or complexity from transmission Raman methods.