Advancements in Drug Quality Control Analysis: High Performance Thin-Layer Chromatography Densitometry Method with Greenness Profile Evaluation

In a recent study published in the Journal of Separation Science, research scientists from Beni-Suef and Nahda Universities in Beni-Suef, Egypt presented what they believe to be a methodological breakthrough in routine drug quality control analysis. Their study focused on commonly used antihypertensive drugs, specifically beta blockers (bisoprolol fumarate and carvedilol) and a diuretic drug (furosemide) (1).

Viersen, Germany - July 9. 2023: Closeup of package Carvedilol alpha and beta blocker pills from 1 A pharma | Image Credit: © Ralf - stock.adobe.com

The researchers developed a high performance thin-layer chromatography (HPTLC) densitometry method to determine the concentration of the aforementioned drugs. The mobile phase consisted of chloroform:methanol:ethyl acetate:ammonia (6:2:2:0.2 by volume), and detection was performed at 240 nm. This innovative approach allowed for the simultaneous determination of bisoprolol fumarate, carvedilol, and furosemide both in their pure forms and in pharmaceutical dosages. The concentration ranges were established as 5–25, 1–7, and 1–3.5 μg/band for bisoprolol fumarate, carvedilol, and furosemide, respectively.

The efficiency of the chosen HPTLC method, according to the authors, lies in its simplicity, speed, and cost-effectiveness; they said it is an attractive option for routine analysis in quality control laboratories. Notably, the simultaneous determination of the three drug tablets in one step not only enhances efficiency but also aligns with the principles of green chemistry.

HPTLC offers a viable alternative to traditional high performance liquid chromatography (HPLC) in addition to addressing the need for time-saving and cost-effective solutions in routine drug quality control. The research team said their study, and the method therein, adheres to the International Conference of Harmonization (ICH) guidelines, with the established procedures successfully validated.

The validation process included a statistical comparison with reported reversed-phase–HPLC methods using Student's t-test and F-test. What the authors found was that there was no significant difference between the results obtained from the HPTLC method and conventional HPLC methods. This indicated that the proposed HPTLC platform was not only efficient but also comparable in accuracy to established techniques, reinforcing its suitability for routine drug quality control analysis.

In conclusion, the research presented by these authors introduces a noteworthy advancement in drug quality control analysis, showcasing the potential of HPTLC densitometry with a greenness profile evaluation. The simplicity, speed, and cost-effectiveness of this method all help to position it as a valuable tool for laboratories engaged in routine analysis of antihypertensive drug combinations. As the pharmaceutical industry continues to evolve, such innovative approaches contribute to the ongoing quest for efficient and sustainable analytical methodologies.

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Reference

(1) Abdelhamid, N. S.; Abdelaleem, E. A.; Lashien, A.; Amin, M. M.; Tohamy, S. I. The Improvement of Routine Drug Quality Control Analysis of Some Antihypertensive Drugs Using High-Performance Thin-Layer Chromatography Densitometry Method with Greenness Profile Evaluation. J. Sep. Sci. 2023, e2300608. DOI: 10.1002/jssc.202300608