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  • 1 Beni-Suef University, Alshaheed Shehata Ahmed Hegazy St., Beni-Suef 62514, Egypt
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Summary

Three simple, sensitive, and validated methods were developed for the quantitative determination of fosinopril sodium (FOS) and hydrochlorothiazide (HCZ) in the presence of an HCZ impurity, chlorothiazide (CZ). The first method (I) was the ratio difference spectrophotometric method (RD), in which a standard spectrum of 8 µg mL−1 HCZ was used as a divisor, and the difference in amplitude values at 204.6 and 231.2 nm and 290 and 302.6 nm was used for the determination of FOS and CZ, respectively. Meanwhile, for the determination of HCZ, a standard spectrum of 6 µg mL−1 CZ was the chosen divisor, and the amplitude difference at 275 nm and 293.6 nm was selected for the calculation of its concentrations. The second method (II) was mean centering of ratio spectra spectro-photometric method (MCR), which depended on the implementation of the mean-centered ratio spectra in two successive steps and the measurement of the amplitudes of the mean-centered second ratio spectra at 243.4 nm for CZ and peak-to-peak amplitudes at 215.6 and 215.8 nm for FOS and at 223.8 and 224 nm for HCZ. On the other hand, the third method (III) was thin-layer chromatography (TLC)-densitometry at which the chromatographic separation of this ternary mixture was performed using pre-activated silica gel 60 F254 TLC plates and a developing system mixture consisting of ethyl acetate-chloroform-methanol-formic acid (60:40:5:0.5, by volume) with ultraviolet (UV) scanning at 215 nm. The developed methods were validated according to the International Conference of Harmonization (ICH) guidelines and were successfully used for the determination of FOS and HCZ in their pharmaceutical formulations. Also, a statistical comparison between the developed methods and the reported HPLC method was attained. Using Student's t-test and F-test, the results confirmed that there was not any significant difference between them regarding accuracy and precision.

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Journal of Planar Chromatography - Modern TLC
Language English
Size A4
Year of
Foundation
1988
Volumes
per Year
1
Issues
per Year
6
Founder Akadémiai Kiadó
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Address
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Springer Nature Switzerland AG
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ISSN 0933-4173 (Print)
ISSN 1789-0993 (Online)

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