Multivariate Model Update Chemometric Methods for Determination of Prednisolone and Esomeprazole in Spiked Human Plasma: A Comparative Study.

BACKGROUND

Prednisolone (PRD) is an immunosuppressant and anti-inflammatory drug, although it may cause peptic ulcers as a side effect. Esomeprazole (ESO) is used for the treatment of peptic ulcers, therefore the two drugs are co-administered in cases of organ transplantation and autoimmune diseases.

OBJECTIVE

This work aims to determine the two drugs simultaneously, in bulk, and in spiked human plasma by eliminating the overlap of their spectra and the interference of the plasma matrix.

METHODS

Two simple and effective updated chemometric models-principal component analysis (PCA) and partial least squares (PLS)-were established using UV spectrophotometric data.

RESULTS

The two updated models have been validated according to the U.S. Food and Drug Administration guidelines with acceptable results. The results were statistically compared with those of the reported methods, where no significant difference was found, indicating the validity of the developed methods. The two updated models have been successfully applied for prediction of the proposed drugs with good accuracy and precision.

CONCLUSION

The two updated models are simple, rapid, sensitive, and precise and could be easily applied in quality control laboratories for determination of PRD and ESO, without any preliminary separation steps or interference from plasma matrixes.

HIGHLIGHTS: Two model updated chemometric models, PCA and PLS, were established for determination of PRD and ESO in spiked human plasma using UV spectrophotometric data.