Vis-NIR analytical technique enables significant cost and time savings compared to standard reference analysis.
Pharmaceutical quality control is an indispensable part of the pharmaceutical manufacturing process.
One of the key quality parameters that has to be determined is the uniformity of dosage units. The pharmaceutical manufacturer has to ensure the consistency of the product. He needs to demonstrate that each batch has a content of the active pharmaceutical ingredient (API) within a narrow range around the target concentration. This is realized using the determination of the content uniformity.
Content uniformity
The general procedure for the determination of this parameter involves a selection of not less than 30 units from a specific batch.
HPLC
Subsequently, these samples need to be analysed using an appropriate method. Usually, high performance liquid chromatography (HPLC) is used as a test method. This means that each of the dosage unit needs to be dissolved and analysed by this technique.
High running costs
The main disadvantage of this procedure is high running costs, caused through the use of chemicals in the time-consuming dissolution procedure and in the analysis step itself. HPLC requires a solvent or usually a mixture of multiple solvents, as a mobile phase.
The costs of the solvents can be significant since the analysis can take up to 60 minutes.
For example, the analysis of 30 samples with 60 minutes duration and a flow rate of 1 mL/min requires 1.8 L solvent and takes in total 30 hours.
Alternative: Near-infrared spectroscopy (NIR)
Alternatively, the manufacturer can utilize near-infrared spectroscopy (NIR). This technology was recognized by regulatory bodies as a tool for quality control offline and online. Using NIR spectroscopy, a tablet can be analysed as-is without any sample preparation.
Significant cost and time savings
Furthermore, the result of a single analysis is available within a minute, which shortens the duration of the content uniformity tests to 30 minutes. This leads to significant time savings compared to the classical analysis.
Additionally, this technique enables a possibility to reduce significantly running costs of QC lab since the analysis is performed without the use of chemicals such as solvents.
The NIR Application Note NIR–063 “Content uniformity of pharmaceutical solid dosage forms using Vis-NIR spectroscopy” demonstrates different application possibilities of Metrohm Vis-NIR analyzers for the determination of content uniformity parameters in pharmaceutical products such as tablets.
This unique analytical technique enables significant cost and time savings compared to standard reference analysis.
