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Nevin Manimala Statistics

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

J AOAC Int. 2021 Sep 3:qsab114. doi: 10.1093/jaoacint/qsab114. Online ahead of print.

ABSTRACT

BACKGROUND: Prednisolone is immunosuppressant and anti-inflammatory drug; it may cause peptic ulcers as a side effect. Esomeprazole is used for treatment of peptic ulcers therefore; the two drugs are co-administered in case of organ transplantation and autoimmune diseases.

OBJECTIVE: This work aims to determine simultaneously the two drugs together in bulk and spiked human plasma by eliminating the overlapping between the spectra of each other and the interference of plasma matrix.

METHODS: Two simple and effective model updated chemometric models called principal component analysis (PCA) and partial least square (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 accepted 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 results regarding 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 matrix.

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

PMID:34478551 | DOI:10.1093/jaoacint/qsab114

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