Using Handheld NIR Spectrophotometers for the Quantification of Ciprofloxacin and Metronidazole Tablet Samples

Researchers from the University of Liège and the University of Yaoundé have pioneered a cost-effective method using handheld NIR spectrophotometers to detect substandard drugs in low-resource areas to improve pharmaceutical quality control. Their study, published in Applied Spectroscopy, demonstrated the successful transfer and application of robust calibration models, offering a promising solution to combat poor-quality medicines in regions with limited resources (1).

The research team sought to combat the use of ineffective medications, which is a growing problem in low-resource areas. Near-infrared (NIR) spectroscopy has emerged as a possible technique that could combat this problem.

The scientists aimed to develop, validate, and transfer methods for quantifying the contents of ciprofloxacin and metronidazole tablets using a handheld NIR spectrophotometer in transmission mode, referred to as NIR-M-T1, coupled with chemometrics, specifically the partial least squares regression (PLSR) algorithm (1). This approach was designed to offer a cost-effective and rapid alternative to traditional laboratory methods for drug quality assessment (1).

The study initially validated quantitative PLSR models in Belgium, characterized by a temperate oceanic climate. Subsequently, the models were transferred to Cameroon, a tropical climate zone, where researchers encountered challenges in accurately predicting new validation series using the initial models (1). To overcome this hurdle, two augmentation strategies were devised to make the predictive models more robust against environmental factors. These strategies incorporated the potential variability linked to environmental effects in the initial calibration sets (1).

The resulting models were then put to the test during in-field analysis of ciprofloxacin and metronidazole tablet samples collected from three different cities in Cameroon. The content results obtained using both augmentation strategies closely aligned and were not statistically different. However, the first strategy was noted for its ease of implementation, whereas the second strategy excelled in terms of model diagnostic measures and accuracy profiles (1).

This research revealed that two samples from the collected tablets were found to be noncompliant in terms of their content (1). These results were subsequently confirmed using high-performance liquid chromatography (HPLC), which is considered the reference method for pharmaceutical content analysis.

As a result, this study serves as another blueprint for combating substandard medicines, especially in regions with limited resources. The utilization of low-cost handheld NIR spectrophotometers, coupled with robust calibration models, could significantly improve the efficiency and accuracy of drug quality assessment, ultimately safeguarding public health (1).

The researchers believe that this innovative approach could serve as a blueprint for similar initiatives in other low-resource areas, offering hope in the ongoing battle to ensure the safety and effectiveness of pharmaceuticals worldwide.

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Reference

(1) Tchounga, C. A. W.; Marini, D.; Nga, E. N.; Hamuli, P. C.; Mballa, R. N.; Hubert, P.; Ziemons, E.; Sacre, P.-Y. In-Field Implementation of Near-Infrared Quantitative Methods for Analysis of Medicines in Tropical Environments. Appl. Spectrosc. 2023, ASAP. DOI: 10.1177/00037028231201653