HPTLC Method Development and Validation for Simultaneous Estimation of Rifaximin and Metronidazole Benzoate in Combined Tablet Dosage Form
Year: 2026
Type: article
Abstract: Rifaximin is a non-systemic antibiotic with low oral bioavailability. It is soluble in methanol, chloroform, acetone and ethyl acetate. Metronidazole is a nitroimidazole derivative which have broad spectrum of amoebicidal activity against protozoa and some anaerobic bacteria. Practically, this drug is insoluble in water but soluble in Ethanol (13 mg/ml) and very freely soluble in (DMSO) (55 mg/ml). The combination of Rifaximin and Metronidazole has shown great evidence of eradication in case of H.pylori infection and in traveller diarrhoea. This Combination is exerting maximum effect at dose of 200 mg of Rifaximin and 400 mg of Metronidazole. High-Performance Thin-Layer Chromatography (HPTLC) is a form of thin-layer chromatography (TLC) that provides superior separation power using optimized coating material, novel procedures for mobile-phase feeding, layer conditioning and improved sample application. The method was developed using mobile phase toluene: chloroform: methanol: n-butanol (4:3:3:0.5 v/v/v), stationary phase silica gel G F254 (Precoated TLC plates) at the wavelength of 311 nm. Analytical method validation establishes documented evidence that the procedure adopted for a test is fit for the intended purpose in terms of quality, reliability and consistency of results. Conclusion: HPTLC method was developed for estimation of Rifaximin and Metronidazole from their pharmaceutical dosage form. The developed method was validated and found to be simple, precise, accurate, and robust, as it separates components with good chromatographic criteria. All results were found satisfactory so, development and validation method can be applied to the tablet dosage form.
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: bronze
OpenAlex ID: W7163582318