High-performance thin-layer chromatographic method for simultaneous determination of some Angiotensin II Receptor Antagonists with amlodipine in spiked human plasma with UV detection

高效薄层色谱法同时测定加标人血浆中某些血管紧张素II受体拮抗剂和氨氯地平,紫外检测

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Abstract

A simple, sensitive, precise, and cost-effective high-performance thin-layer chromatographic method has been developed and validated for the simultaneous determination of Amlodipine and some Angiotensin II Receptor Antagonist drugs, including Olmesartan, Telmisartan, Candesartan, Losartan, and Irbesartan, in spiked human plasma. The HPTLC analysis utilized a mobile phase consisting of toluene: ethyl acetate: methanol: acetone: acetic acid (6:1.5:1:0.5:1, v/v/v/v/v) on an aluminum-backed layer of silica gel 60 F254. Amlodipine demonstrated a linear relationship within the range of 60-600 ng/band, while the AIIRA drugs showed linearity within the range of 90-900 ng/band. The proposed method exhibited good linearity, with correlation coefficients (r) ranging from 0.9939 to 0.9998 for all five studied mixtures. The method was validated according to International Council for Harmonization guidelines for linearity, accuracy, precision, robustness, and detection and quantitation limits. Amlodipine and the investigated Angiotensin II Receptor Antagonist drugs were successfully detected and quantified in both bulk drug and plasma samples, yielding high recovery percentages and low standard deviation values. The greenness of the proposed HPTLC method has been evaluated using the standards of greenness profile (AGREE and GAPI) and Eco-Scale.

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