What is it about?
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). The second method (II) was the 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. And the third method (III) was thin-layer chromatography (TLC)‒densitometry at which the chromatographic separation of this ternary mixture was performed using 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 meth- ods 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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Why is it important?
Fosinopril sodium (FOS) is chemically identified as sodium(2S,4S)-4-cyclohexyl-1-(2-{[2-methyl-1-( propionyloxy ) propoxy](4-phenyl butyl)phosphoryl}acetyl)pyrrolidine-2-carboxylate. It is the only angiotensin-converting enzyme (ACE) inhibitor which contains a phosphate group, which makes it a safer choice than other ACE inhibitors for the treatment of hypertension and some types of chronic heart failure, especially for patients with impaired kidney function as it is eliminated from the body by both renal and hepatic pathways
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This page is a summary of: Development and Validation of Different Spectrophotometric and High-Performance Thin-Layer Chromatographic Methods for the Determination of Fosinopril Sodium, Hydrochlorothiazide, and Chlorothiazide as Hydrochlorothiazide Impurity, JPC - Journal of Planar Chromatography - Modern TLC, October 2019, Akademiai Kiado,
DOI: 10.1556/1006.2019.32.5.9.
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