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A versatile high-performance thin-layer chromatographic method for the simultaneous determination of five antihypertensive drugs: method validation and application to different pharmaceutical formulations

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Abstract

A selective high-performance thin-layer chromatography (HPTLC) densitometric method has been developed for the simultaneous determination of five antihypertensive drugs, atenolol (ATE), amlodipine (AML), losartan (LOS), hydrochlorothiazide (HCT), and telmisartan (TEL). Chromatographic separation was performed on HPTLC silica plates 60 F254 as the stationary phase, using chloroform‒toluene‒methanol‒acetone‒formic acid (4:3:1.5:2.6:0.03, V/V) as the mobile phase with retardation factor (RF) values of 0.07, 0.12, 0.45, 0.56, and 0.64, respectively. The plates were scanned at 254 nm. The method was validated according to the International Council for Harmonization (ICH) guidelines. Calibration curves were constructed over the ranges of 1.0‒25.0 µg/band, 1.0‒20.0 µg/band, 1.0‒25.0 µg/band, 1.0‒20.0 µg/band and 1.0‒25.0 µg/band of ATE, AML, LOS, HCT, and TEL, respectively. Limits of detection were found to be 0.30, 0.13, 0.23, 0.14, and 0.19 µg/band, respectively. Effects of mobile phase composition and detection wavelength were investigated to achieve optimum chromatographic separation. Statistical comparison between the proposed and official methods was performed. The proposed method was successfully applied to the analysis of the drugs’ dosage form combinations. The proposed HPTLC method offers a generic simple and reliable chromatographic alternative for the routine quality control analysis.

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Correspondence to Ahmed H. Nadim.

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Saeed, S., Nadim, A.H., Yehia, A.M. et al. A versatile high-performance thin-layer chromatographic method for the simultaneous determination of five antihypertensive drugs: method validation and application to different pharmaceutical formulations. JPC-J Planar Chromat 34, 467–477 (2021). https://doi.org/10.1007/s00764-021-00133-5

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  • DOI: https://doi.org/10.1007/s00764-021-00133-5

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