Determination of Cefalexin in Pharmaceutical Formulations: A Comparative Study Between the Digital Image Colorimetry (DIC) Method and the Reference RP-HPLC Method

Abstract

This study aims to perform a precise statistical comparison between the developed Digital Image Colorimetry (DIC) method for the determination of cephalexin in pharmaceutical formulations and the reference method adopted by the British Pharmacopoeia (HPLC–BP). The developed method represents a simple and environmentally friendly analytical approach for drug analysis, without the need for large volumes of organic solvents or sophisticated chromatographic instrumentation.

Two pharmaceutical samples (C1 and S1) were analyzed using both methods, and the effect of measurement time after complex formation on result accuracy was investigated. A measurement time of 4 minutes was found to be optimal for recording the color intensity.

The results obtained from both methods were statistically analyzed using T and F tests to evaluate the agreement in terms of accuracy and precision. The findings showed no significant differences between the values obtained by the two methods at a significance level of P > 0.05, confirming that the developed method can be adopted as an environmentally friendly, cost-effective, and time-saving alternative to the reference method.

Moreover, the greenness assessment of the methods indicated that the DIC approach is more consistent with the principles of green chemistry, due to its lower consumption of solvents, time, and energy compared to the HPLC reference method. The total analytical eco-scale penalty points (PPs) for the developed method were only 6, in contrast to 26 points for the reference HPLC method, emphasizing its superiority in terms of environmental friendliness and sustainability.