Abstract
Satranidazole is a new nitroimidazole derivative with potent antiamoebic action and is available in market in the form of tablet and dry syrup either alone or in combination with Ofloxacin. The present study involves the development of simple, accurate, precise, and reproducible reversed phase high performance liquid chromatography (RP-HPLC) method for determination of Satranidazole from its granular dosage form. Isocratic elution at a flow rate of 1.0 mL/min was employed on BDS Hypersil C18 (250 mm × 4.6 mm, 5 μm) column at 25°C temperature. The mobile phase consists of 0.16% v/v orthophosphoric acid solution, pH 3: acetonitrile in the ratio of 60 : 40 v/v. The UV detection wavelength was 320 nm, and 20 μL sample was injected. The retention time for Satranidazole was about 4.3 minutes. The method was validated for various parameters such as system suitability, precision, recovery, robustness, and ruggedness as per ICH guidelines. The validated RP-HPLC method was found to be specific, linear, precise, and accurate and can be successfully employed for the assay of Satranidazole taste masked granules coated with Eudragit E100 and marketed tablets.
Highlights
IntroductionSatranidazole (STZ) is a new nitroimidazole derivative with potent antiamoebic action
Satranidazole (STZ) is a new nitroimidazole derivative with potent antiamoebic action. It is used in the treatment of intestinal and hepatic amoebiasis, giardiasis, trichomoniasis, and anaerobic infections
No stability indicating method is available in the official compendia using high performance liquid chromatograph (HPLC) for analyzing Satranidazole in dosage forms till
Summary
Satranidazole (STZ) is a new nitroimidazole derivative with potent antiamoebic action. It is used in the treatment of intestinal and hepatic amoebiasis, giardiasis, trichomoniasis, and anaerobic infections. Literature survey revealed that there are various methods for individual determination of STZ by using RP-HPLC [3], HPLC [4], HPTLC [5, 6], and spectrophotometer [7] and simultaneous estimation of STZ and Ofloxacin in tablet dosage form [8, 9]. Satranidazole is not official in any pharmacopoeia and no stability indicating method is reported for determination of Satranidazole in tablets and granular formulations.
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